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H.P. STATE

COUNCIL

DRUG AND THERAPYBULLETIN

HIMACHAL PRADESH STATE PHARMACY COUNCIL

Toll Free 18001210443

DRUG INFORMATION CENTER

LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]

Contents |

Editorial

Drug Updates

Pharma News

Local News

Which kind of queries can be asked from Drug Information Center?

Issue: 14 ● Volume: 2 ● Nov 2018

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,

Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]

2

DRUG AND THERAPY BULLETIN

Content

EDITORIAL

Patron

Mr. Gopal Krishan Sharma and Dr. Ran Singh

Editor-in-chief

Dr. Kamlesh Naik and Dr. M.S. Ashawat

Co-Editors

Dr. Vinay Pandit and Mr. Ankush Sharma

Advisory Board

Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma, Dr. Poonam Sandhu, Dr. Rajender Guleria,

Mr. Arvind Kumar, Mr. Bihari Lal Gupta, Mr, Hemant Sharma, Mr. Rakesh Chandel, Mr. Praveen Upadhya, Mr. Kamashwar Chauhan, Mr.

Lokesh Kumar, Mr. Vishal Kumar, Mr. Y.S.Chandel, Mr. Birbal Sharma, Mr. Manoj Kumar, Mr. Yogesh Verma, Mr. Surender Nadda,

Dr. Parshuram

DRUG UPDATES

Lorbrena® for ALK positive NSCLC .......................................................................................................4

Sympazan™oral film for LGS ................................................................................................................4

New opiod for hospital use ..................................................................................................................4

Hyrimoz™: Third humira biosimilar .......................................................................................................5

Invokana for CV risk reduction ..............................................................................................................5

Keytruda Plus chemo for NSCLC ...........................................................................................................5

Xyrem® now for Pediatric cataplexy ......................................................................................................5

Bijuvia™ for Menopausal hot flashes .....................................................................................................6

Xofluza™ for flu treatment ...................................................................................................................6

Dupixent® now for Asthma ..................................................................................................................6

Rituxan®: New dosing for GPA/MPA .....................................................................................................6

3



Talzenna™ for metastatic breast cancer .................................................................................................7

Yutiq™ for Uveitis ...............................................................................................................................7

New Treatment for ADA-SCID ...............................................................................................................7

Tegsedi™: Approved ............................................................................................................................7

Nuzyra™ for CABP and ABSSS .............................................................................................................8

Seysara™ for moderate to severe acne ..................................................................................................8

Xyosted™ SubQ Testosterone ...............................................................................................................8

PHARMA NEWS

HC impleads online medicine traders in plea seeking ban on e-pharmacies ...............................................9

Ministry of Finance clarifies on procedure in respect of return of expired drugs under GST ...........................9

NPPA fixes retail price of 68 drug formulations .....................................................................................10

Antibiotics becoming ineffective for neonates .......................................................................................10

More than 90% of the world’s children breathe toxic air every day: WHO ................................................10

Banned ingredients in diet pills putting Indians at risk' ..........................................................................11

U.S. scientists create new drug to sustain oxygen-starved hearts ............................................................11

DCGI approves Brintellix in India for Major Depressive Disorder ..............................................................11

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old .........................12

FDA approves new DNA-based test to determine blood compatibility ......................................................12

FDA Removes 7 Synthetic Flavoring Substances from Food Additives List ................................................12

LOCAL NEWS

दवा उद्योगों को नालागढ़ में ही मिलेगा कच्चा माल ................................................................................13

जुबीलेंट कैदीस्टा ने वापस बुलाई १.५८ लाख बोतले ं ..................................................................................13

Content (Continued)



4


DRUG UPDATES

®Lorbrena for ALK positive NSCLC

®On November 2, 2018, the US FDA approved Lorbrena

(lorlatinib) oral tablets indicated to treat patients with

anaplastic lymphoma kinase (ALK)-positive metastatic

non-small cell lung cancer (NSCLC) whose disease has

progressed on crizotinib and at least one other ALK

inhibitor or whose disease has progressed on alectinib or

ceritinib as the first ALK inhibitor therapy for metastatic

disease. The approval of Lorbrena®, was based on a

clinical trial in which patients treated with lorlatinib had

a higher overall response rate.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2108

68s000lbl.pdf.

Sympazan™oral film for LGS

On November 2, 2018, the US FDA approved

Sympazan™ (clobazam) oral film indicated for

adjunctive treatment of seizures associated with Lennox-

Gastaut syndrome (LGS) in patients 2 years of age or

older. Sympazan™oral film offers a new formulation as

clobazam is currently only marketed as oral tablets and

oral suspension. Sympazan™, which provides for easier

administration to patients with LGS who often have

difficulty swallowing tablets and suspension, was

demonstrated to be bioequivalent to clobazam tablets

and has a comparable safety profile.



33s000lbl.pdf.

New opiod for hospital use

On November 2, 2018, the US FDA approved Dsuvia™

(sufentanil citrate) sublingual tablets indicated for use in

adults in a certified medically supervised healthcare

setting (e.g., hospitals, surgical centers, and emergency

departments) for the management of acute pain severe

enough to require an opioid analgesic and for which

alternative treatments are inadequate. Dsuvia™, a 30-

mcg sublingual tablet administered by a healthcare

professional via a single-dose prefilled applicator, will be

available only through the Dsuvia™ Risk Evaluation and

Mitigation Strategy (REMS) due to the potential for life-

threatening respiratory depression from accidental

exposure.

5





28s000lbl.pdf.

Hyrimoz™: Third humira biosimilar

On October 31, 2018, the US FDA approved Hyrimoz™

(adalimumab-adaz) subQ injection indicated for the

treatment of rheumatoid arthritis, juvenile idiopathic

arthritis in patients 4 years of age or older, psoriatic

arthritis, ankylosing spondylitis, adult Crohn disease,

ulcerative colitis, and plaque psoriasis. Hyrimoz™, the

®third biosimilar for Humira to gain FDA approval, was

approved based on its high degree of similarity to the

reference product and a biosimilarity study used to

confirm safety and efficacy.



71lbl.pdf.

Invokana for CV risk reduction

On October 30, 2018, the US FDA approved a new

®indication for Invokana (canagliflozin) oral tablets to

reduce the risk of major adverse cardiovascular (CV)

events (CV death, nonfatal myocardial infarction (MI)

and nonfatal stroke) in adults with type 2 diabetes

®mellitus and established CV disease. Invokana , which

is now the only approved oral diabetes therapy approved

to reduce CV risks, demonstrated a greater reduction

than placebo in the combined risk of MI, stroke, and CV

death in the CANVAS trial.

Prescribing information can be found at: http://www.

janssen labe ls .com/package- inse r t /p r oduct -

monograph/prescribing-information/INVOKANA-

pi.pdf.

Keytruda Plus chemo for NSCLC

®On October 30, 2018, the US FDA approved Keytruda

(pembrolizumab) IV injection in combination with

carboplatin and either paclitaxel or nab-paclitaxel for the

first-line treatment of patients with metastatic squamous

non-small cell lung cancer (NSCLC). Keytruda, which is

the first anti-PD-1 therapy to gain FDA approval for this

indication, was approved based on demonstrated

efficacy compared with chemotherapy alone in the

KEYNOTE-407 trial.

Pr e s c r i b i n g i n f o rma t i on can be f ound a t :

https://www.accessdata.fda.gov/drugsatfda_docs/label/

2018/125514s041lbl.pdf.

Xyrem® now for Pediatric cataplexy

On October 29, 2018, the US FDA approved an

®expanded indication for Xyrem (sodium oxybate) oral

solution to treat cataplexy or excessive daytime

sleepiness in patients 7 years of age or older with

®narcolepsy. Xyrem , which is already approved for the

same indication in adult patients, was approved in

pediatric patients 7 years of age or older based on data

from the EXPRESS clinical trial in which sodium oxybate

resulted in fewer weekly cataplexy attacks compared

with placebo.



96s030lbl.pdf.



6


Bijuvia™ for Menopausal hot flashes

On October 29, 2018, the US FDA approved Bijuvia™

(estradiol/progesterone) oral capsules for the treatment

of moderate to severe vasomotor symptoms (ie, hot

flashes or flushes) due to menopause in women with a

uterus. Bijuvcombination hormone therapy in a single

oral capsule to gia™ is the first bioidentical estradiol and

progesterone ain FDA approval. In the Replenish Trial,

Bijuvia™ demonstrated a significant reduction from

baseline in frequency and severity of hot flashes

compared with placebo.

Prescribing information can be found at: https://

www.bijuva.com/pi.pdf.

Xofluza™ for flu treatment

On October 24, 2018, the US FDA approved Xofluza™

(baloxavir marboxil) oral tablets indicated for the

treatment of acute uncomplicated influenza (flu) in

patients 12 years of age or older who have been

symptomatic for no more than 48 hours. Xofluza™ is the

first single-dose oral formulation for flu treatment to gain

FDA approval. Safety and efficacy were demonstrated in

2 clinical trials in which patients treated with baloxavir

marboxil had a shorter time to alleviation of flu

symptoms compared with those treated with placebo.


gene.com/download/pdf/xofluza_prescribing.pdf.

®Dupixent now for Asthma

On October 19, 2018, the US FDA approved a new

®indication for Dupixent (dupilumab) subQ injection as

an add-on maintenance therapy in patients 12 years of

age or older with moderate-to-severe asthma with an

eosinophilic phenotype or with oral corticosteroid-

®dependent asthma. Dupixent , which is already

approved for use in adults with moderate-to-severe

atopic dermatitis, was approved for asthma based on

data from 3 clinical trials in which dupiliumab reduced

exacerbations, improved lung function, and resulted in a

greater reduction in average daily oral corticosteroid use

compared with placebo.



55s007lbl.pdf.

®Rituxan : New dosing for GPA/MPA

On October 19, 2018, the US FDA approved an update

®to dosing for Rituxan (rituximab) IV injection to include

fo l low-up t reatment o f adu l t pat ients wi th

granulomatosis with polyangiitis (GPA) and microscopic

polyangiitis (MPA) who have achieved disease control

with induction treatment. Approval for the new dosing

comes after a study demonstrated fewer major relapses

by month 28 compared with treatment with

azathioprine. Rituxan, in combination with gluco-

corticoids, continues to be the only FDA-approved

therapy for these rare and potentially life-threatening

blood vessel disorders.

Prescribing information for rituximab can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/label/

2018/103705s5451lbl.pdf.

7



Talzenna™ for metastatic breast cancer

On October 16, 2018, the US FDA approved Talzenna™

(talazoparib) oral capsules for the treatment of adult

patients with deleterious or suspected deleterious

germline BRCA-mutated (gBRCAm) HER2-negative

locally advanced or metastatic breast cancer. Patients

must be selected for therapy based on an FDA-approved

companion diagnostic test for talazoparib. Talzenna™

approval was based on the EMBRACA trial in which

there was a significant improvement in progression-free

survival demonstrated with talazoparib compared with

chemotherapy. The FDA a lso approved the

BRACAnalysis CDx test to identify patients with breast

cancer with deleterious or suspected deleterious

gBRCAm who are eligible for talazoparib.



51s000lbl.pdf.

Yutiq™ for Uveitis

On October 15, 2018, the US FDA approved Yutiq™

(fluocinolone acetonide) intraocular implant for the

treatment of chronic non-infectious uveitis affecting the

posterior segment of the eye. Yutiq™, which is the first

long-acting fluocinolone acetonide intravitreal implant to

gain FDA approval, is delivered consistently over 36

months using a drug delivery technology designed by the

manufacturer.

Prescribing information can be found at: https://

e y epo i n t pha rma . c om /wp - con t en t / up l o ad s /

2018/10/YUTIQ-USPI-20181013.pdf.

New Treatment for ADA-SCID

On October 5, 2018, the US FDA approved Revcovi™

(elapegademase-lvlr) intramuscular injection for the

treatment of adenosine deaminase severe combined

immune deficiency (ADA-SCID) in pediatric and adult

patients. The approval is based on 2 clinical trials that

demonstratedbolites, and improved total lymphocyte

counts increased adenosine deaminase activity,

r educed concen t r a t i ons o f t o x i c me taw i th

elapegademase-lvlr.

Prescribing information for elapegademase-lvlr can be

f ound a t h t t p s : / /www.acce s sda t a . f da . g o v /

drugsatfda_docs/label/2018/761092s000lbl.pdf.

Tegsedi™: Approved

On October 5, 2018, the US FDA approved Tegsedi™

(inotersen) subcutaneous injection for the treatment of

the polyneuropathy of hereditary transthyretin-mediated

amyloidosis in adults. Tegsedi™ is the first and only

RNA-targeted therapy that reduces the production of

transthyretin protein with a once-weekly subcutaneous

injection. Approval was based on the Phase 3 NEURO-

TTR study that demonstrated better outcomes in both

co-primary endpoints in patients treated with inotersen



8


compared with those treated with placebo. Tegsedi™,

which carries a black box warning regarding the potential

of thrombocytopenia and glomerulonephritis, is

available only through the Tegsedi™ REMS Program.

Prescribing information for inotersen can be found at

https://www.accessdata.fda.gov/drugsatfda_docs/label

/2018/211172lbl.pdf.

Nuzyra™ for CABP and ABSSS

On October 2, 2018, the US FDA approved Nuzyra™

(omadacycline) IV injection and oral tablets indicated for

the treatment of adult patients with community-acquired

bacterial pneumonia (CABP) and acute bacterial skin

and skin structure infections (ABSSSI). Nuzyra™ which

was approved based on data from multiple clinical trials

which demonstrated safety and efficacy, is specifically

designed to overcome tetracycline resistance.

Prescribing information can be found at: http://nuzyra.

com/PI.pdf.

Seysara™ for moderate to severe acne

On October 2, 2018, the US FDA approved Seysara™

(sarecycline) oral tablets indicated for the treatment of

inflammatory lesions of non-nodular moderate to severe

acne vulgaris in patients 9 years of age or older.

Seysara™, which is taken once daily, is a narrow

spectrum tetracycline antibiotic that has anti-

inflammatory properties.



21s000lbl.pdf.

Xyosted™ SubQ Testosterone

On October 1, 2018, the US FDA approved Xyosted™

(testosterone enanthate) subQ injection indicated for

testosterone replacement therapy in adult males for

conditions associated with a deficiency or absence of

endogenous testosterone. Xyosted™, which is the first

subQ route testosterone enanthate product to gain FDA

approval, will be available in 50, 75, and 100 mg

strengths for once-weekly self-administration.



63s000lbl.pdf.

9



PHARMA NEWS

HC impleads online medicine

traders in plea seeking ban on e-pharmacies

The Madras High Court allowed firms involved in online

sale of medicines to be impleaded in a petition seeking a

ban on their business. Justice R Mahadevan, who has

granted an interim stay on sale of medicines online by

those not having required license, impleaded the

petit ioners, including New Delhi-based 1MG

Technologies Private Limited, as party to the petition

filed by the Tamil Nadu Chemists and Druggists

Association (TNCDA).

TNCDA has sought a ban on online sale of medicines

contending that purchasing drugs from unlicensed online

stores can be risky as they may sell fake, expired,

contaminated or unapproved drugs that are dangerous to

the health of patients. E-pharmacy was an initiative to

help the caregivers select the most appropriate health

care services at the best possible price, the counsels

said. The e-pharmacists have entered into facilitation

agreements with various third-party pharmacies across

the country and they neither stocked medicines nor were

having any shop. The orders were placed based on

prescription issued by the doctors, they said. Hence the

online firms were not obligated to procure a license under

the Drugs and Cosmetics Rules 1955, they reasoned.

Ref: www. health.economictimes.indiatimes.com

Ministry of Finance clarifies on procedure in

respect of return of expired drugs under GST

The Central Board of Indirect Taxes and Customs (CBITC)

under the Union finance ministry clarifies on procedure

in respect of return of expired drugs under Goods and

Services Tax (GST). The issues raised in the said

representations have been examined and to ensure

uniformity in the implementation of the law across the

field formations, the Board, in exercise of its powers

conferred under section 168(1) of the Central Goods and

Services Tax Act, 2017 (hereinafter referred to as the

“CGST Act”).

Generally, in the pharmaceutical sector is that the drugs

or medicines (hereinafter referred to as “goods”) are sold

by the manufacturer to the wholesaler and by the

wholesaler to the retailer based on an invoice/bill of

supply as case may be. It is significant to mention here

that such goods have a defined life term which is

normally referred to as the date of expiry. Such goods

which have crossed their date of expiry are colloquially

referred to as time expired goods and are returned to the

manufacturer, on account of expiry, through the supply

chain. The CBITC in a circular on October 26, 2018 said

that the retailer/wholesaler can either return the time

expired goods treating it as fresh supply or can return the

expired goods by issuing credit notes.

In case of return of time expired goods to be treated as

fresh supply, a registered person (other than a composition

taxpayer) can return goods by issuing an invoice for the

same. This will be referred to as return supply. The

wholesaler or manufacturer who is the recipient of such

return supply, shall be eligible to avail input tax credit (ITC)

of the tax levied on the said return supply as specified in

Section 16 of the CGST Act. In case the person returning

the time, expired goods are an unregistered person, he

may return the said goods by issuing any commercial

document without charging any tax on the same. If a

manufacturer destroys the time expired goods, returned by

the retailer/wholesaler, he/she is required to reverse the

ITC availed on the return supply as per clause (h) of sub-

section (5) of section 17 of the CGST Act.

The retailer or wholesaler can return the time expired

goods by issuing a delivery challan. There is no time limit

for the issuance of a credit note in the law except about

the adjustment of the tax liability in case of the credit




10

notes issued prior to September following the end of the

financial year and those issued after it. If a supplier

(manufacturer/wholesaler) receives expired goods till

September, he can issue credit note and the same needs

to be uploaded by him on the common portal.

Subsequently, tax liability can be adjusted by such

supplier provided the recipient (wholesaler/retailer) has

either not availed the ITC or or if availed has reversed the

ITC so availed against the goods being returned. If a

supplier (manufacturer/wholesaler) receives expired

goods after September, he can still issue credit note, but

cannot upload the same on the common portal as he is

not allowed to adjust tax liability by himself.

Ref: www.pharmatutor.org

NPPA fixes retail price of 68 drug formulations

Drug price regulator NPPA fixed prices as well as revised

ceiling and retail prices of 68 formulations, including

those used for treatment of diabetes, blood pressure and

HIV. The National Pharmaceutical Pricing Authority

(NPPA) said while the retail price of 55 scheduled

formulations has been fixed, that of 10 has been revised.

Further, the authority has also fixed ceiling prices of three

scheduled formulations. “NPPA has fixed/revised ceiling

prices/retail prices of 68 formulations under Drugs

(Prices Control) Order, 2013,” it said in a notification.


Antibiotics becoming ineffective for neonates

First line antibiotics are becoming ineffective in

treatment of neonates (under-28-day children) suffering

from different sorts of bacterial infections, shows a study

conducted by city-based doctors. Commonly used

antibiotic cefepime was found ineffective in 36% of

patients suffering from sepsis and another most common

antibiotic amoxiclav was found resistant in 52% of sepsis

cases of neonates included in the study. State’s biggest

government-run child-specialty JK Lon hospital doctors

have come up with a study ‘Clinical and Bacteriological

Profile of Neonatal Sepsis with Emerging Resistance

Patterns’, which has also been published in International

Journal of Contemporary Paediatrics’ November-

December edition. The findings in the study have

expressed concern on neonatal sepsis with emerging

resistance patterns against commonly used antibiotics.

The doctors use first line antibiotics in combination form.

When a suspected sepsis neonate is brought to

the hospital, the doctors immediately provide him

treatment by using combination of drugs such as

cefotaxime and amikacin, cefotaxime and gentamycin,

ampicillin and amikacin and more such combination of

first line antibiotic drugs. In the combination of antibiotic

drugs, doctors use one antibiotic for killing gram positive

organism and one for killing gram negative organism.

They use combination of drug as they are yet to ascertain

what kind of organism (bacteria) is present in the blood

causing sepsis. For ascertaining the kind of bacteria

present in the blood, the doctors conduct culture test.

The report of culture test is issued after 48 hours. The

culture report also shows the sensitivity of drugs on

bacteria causing sepsis.

The study shows the antibiotic sensitivity pattern using

the culture report of 150 confirmed cases (neonates) of

sepsis. The sensitivity pattern shows a high degree of

resistance to commonly used antibiotics belonging to

cephalosporins class and aminoglycoside class such as

ampicillin, gentamycin, amikacin, cefotaxime,

ceftriaxone, cefepime and Amoxiclav.


More than 90% of the world’s children

breathe toxic air every day: WHO

Every day around 93% of the world’s children under the

age of 15 years (1.8 billion children) breathe air that is so

polluted it puts their health and development at serious



11

risk. Tragically, many of them die: WHO estimates that in

2016, 600,000 children died from acute lower

respiratory infections caused by polluted air. A new WHO

report on Air pollution and child health: Prescribing clean

air examines the heavy toll of both ambient (outside) and

household air pollution on the health of the world’s

children, particularly in low- and middle-income

countries. The report is being launched on the eve of

WHO’s first ever Global Conference on Air Pollution and

Health. Air pollution also impacts neurodevelopment

and cognitive ability and can trigger asthma, and

childhood cancer. Children who have been exposed to

high levels of air pollution may be at greater risk for

chronic diseases such as cardiovascular disease later in

life. Newborns and young children are also more

susceptible to household air pollution in homes that

regularly use polluting fuels and technologies for

cooking, heating and lighting

Globally, 93% of the world’s children under 15 years of

age are exposed to ambient fine particulate matter

(PM2.5) levels above WHO air quality guidelines, which

include the 630 million of children under 5 years of age,

and 1.8 billion of children under 15 years. In low- and

middle-income countries around the world, 98% of all

children under 5 are exposed to PM2.5 levels above

WHO air quality guidelines. In comparison, in high-

income countries, 52% of children under 5 are exposed.


Banned ingredients in diet pills putting

Indians at risk

Be careful while popping a pill for weight loss, muscle

building or sexual enhancement. Several dietary

supplements, most of which are widely available in

India, have been found adulterated with unapproved and

even banned pharmaceutical ingredients in the US with

potential to cause serious health risks. At least 776

dietary supplements sold over the counter in the US over

a period of 10 years from 2007 to 2016 were found

containing unapproved pharmaceutical ingredients such

as sildenafil, sibutramine and synthetic steroids —

which have potential to cause side-effects ranging from

stroke to kidney failure and even death, say researchers,

who extracted and analyzed data from the US Food and

Drug Administration's (US FDA) Center for Drug

Evaluation and Research.


U.S. scientists create new drug to sustain

oxygen-starved hearts

U.S. scientists at University of California, San Francisco

(UCSF) have developed a new drug that can restore the

function of oxygen-starved heart tissue under the

conditions of hypoxia. The biopharmaceutical company

has been developing oxygen-delivery therapeutics for the

treatment of cancer, cardiovascular diseases, trauma

and other conditions in which low oxygen levels, or

hypoxia, negatively impact disease outcomes. The new

drug does not cause systemic side effects or overcorrect

with excessive blood oxygenation, which can itself be

toxic. It delivers its precious oxygen cargo only to the

tissues that need it most.


DCGI approves Brintellix in India for Major

Depressive Disorder

Brintellix in India for the treatment of patients suffering

from Major Depressive Disorder(MDD) is approved by

Drug Controller General of India (DCGI). Brintellix, is a

novel multimodal antidepressant, which has been

specifically designed to inhibit serotonin reuptake and

modulate serotonergic receptor activity of the neurons in

the brain of affected patients.





12

FDA approves expanded use of Gardasil 9 to

include individuals 27 through 45 years old

The U.S. Food and Drug Administration approved a

supplemental application for Gardasil 9 (Human

Papillomavirus (HPV) 9-valent Vaccine, Recombinant)

expanding the approved use of the vaccine to include

women and men aged 27 through 45 years. Gardasil 9

prevents certain cancers and diseases caused by the nine

HPV types covered by the vaccine. Gardasil, a vaccine

approved by the FDA in 2006 to prevent certain cancers

and diseases caused by four HPV types, is no longer

distributed in the U.S. In 2014, the FDA approved

Gardasil 9, which covers the same four HPV types as

Gardasil, as well as an additional five HPV types.

Gardasil 9 was approved for use in males and females

aged 9 through 26 years.


FDA approves new DNA-based test to

determine blood compatibility

The U.S. Food and Drug Administration approved ID

CORE XT, a molecular-based assay used in blood

transfusion medicine to help determine blood

compatibility. The assay can be used to determine blood

donor and patient non-ABO red blood cell (RBC) types.

ID CORE XT is the second molecular assay approved for

use in transfusion medicine, and the first to report

genotypes as results. Human blood can be classified into

different groups based on the antigens on the surfaces of

red blood cells. In addition to the ABO blood group

antigens, the presence or absence of other specific blood

group antigens can be important when matching blood

for transfusions since some people develop antibodies to

non-ABO antigens. People who receive repeated blood

transfusions, such as individuals with sickle cell disease,

are more likely to develop these antibodies. If red blood

cells with poorly matched non-ABO antigens are

transfused, red blood cell destruction and a transfusion

reaction can occur in a transfusion recipient.

Traditionally, red blood cell antigens have been identified

using serological methods that involve the use of

antisera, a blood serum that contains antibodies for

testing. Serologic testing present limitations and certain

antisera may be scarce or unavailable.


FDA Removes 7 Synthetic Flavoring

Substances from Food Additives List

The FDA is amending its food additive regulations in

response to two food additive petitions, to no longer

allow for the use of a total of 7 synthetic flavoring

substances and flavor enhancers. The FDA determined

that the data presented in one of the petitions submitted

to the FDA by Breast Cancer Fund, Center for

Environmental Health, Center for Food Safety, Center for

Science in the Public Interest, Consumers Union,

Environmental Defense Fund, Environmental Working

Group, Improving Kids’ Environment, Natural Resources

Defense Council, WE ACT for Environmental Justice, and

Mr. James Huff show that 6 of these synthetic

substances caused cancer in laboratory animals under

the conditions of the studies. The seventh synthetic

flavor is being de-listed because it is no longer used by

industry. The 6 flavoring substances include

synthetically-derived benzophenone, ethyl acrylate,

eugenol methyl ether (methyl eugenol), myrcene,

pulegone, and pyridine. These substances are being

removed from the food additive regulations under the

Delaney Clause of the Federal Food, Drug, and Cosmetic

Act (FD&C Act) (section 409(c)(3) of the FD&C Act). This

clause, enacted in 1958, requires that the FDA cannot

find as safe; i.e., cannot approve, the use of any food

additive that has been found to induce cancer in humans

or animals at any dose.




13

LOCAL NEWS

दवा उ�योग� को नालागढ़ म� ह� �मलेगा क�चा माल |

Ref: Newspaper- Amar Ujala, 29-10-2018

जबील�ट कैद��टा ने वापस बलाई १.५८ लाख बोतल� |ु ु

Ref: Newspaper- Amar Ujala, 20-10-2018




14

Which kind of queries can be asked from Drug

Information Center?

It is the matter of pride for all the population of Himachal

Pradesh that there is drug information center (DIC) in the

state which is giving the services to promote the rational

drug use. Maximum population of state knows that there is

DIC, but they are unaware about the services of the DIC.

They all are confused that which kind of queries they can ask.

There is no any restriction to take the drug query

information by any one. Any person (physician, pharmacist,

nurse, patient, people of community, old persons, students,

researchers etc.) can come in or call in the DIC office to take

drug information.

Following kinds of queries regarding drugs can be asked

from DIC:

Ÿ If patient is administering two medicines at the same

time then he/she before administering the medicine,

can confirm from DIC that this combination is safe or not

safe. If combination will be not safe then it may also be

life threatening.

Ÿ If patient is administering a medicine then he/she can

confirm which kinds of foods have to be avoided.

Ÿ Someone can confirm that use of any specific medicine

in particular condition (like as pregnancy/lactation) is

safe or not safe.

Ÿ General information about drug identification can also

be taken from the DIC, like as use and side/adverse

effects , t ime of administrat ion, durat ion of

administration, dose in different age groups etc. about

any drug.

Ÿ Information about substituted drugs with different

prices can also be provided by DIC.

Ÿ Any updation about medicines can be confirmed from

DIC.

DIC will provide the accurate information on request

without any fear and favor. In short, we can say that DIC can

provide any kind of information about any medicine to

anyone without any cost. Personnel can assess directly, can

call in the DIC office, sent the query by post, by E-mail

Toll Free 18001210443, Phone: 09218428042, 9459220253

Scan this Quick Response (QR)

code to know more

You may download any QR code scanner from

Play Store/iTunes

Personnel can assess directly, can call in the DIC office, sent the query by post, by E-mail on following address.

Note: If any want to publish his/her article in the monthly bulletin of Drug Information Center regarding Pharma updates, they can send their articles with their full address and professional status on the following reference before 25th of every month.

Toll Free 18001210443

DRUG INFORMATION CENTER

HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Jwala Ji, Distt. Kangra HP 177101

Website: www.hpspc.in | Mail ID: [email protected], [email protected]

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