India - CDSCO - Updated List of FDCs (Fixed-Dose-Combinations) Approved for Marketing in India

India’s National Drug Authority, Central Drugs Standard Control Organization (CDSCO) has updated list of approved FDCs (Fixed-Dosed-Combinations Drugs) approved for marketing in India.

A detailed list of these Fixed Dosed Combination Drugs up to July 2014, have been attached here for reference.

Please CLICK HERE to view/download list of approved FDCs (Fixed-Dosed-Combinations Drugs) approved for marketing in India

USFDA: New and Generic Drug Approvals: 29 SEP 2014

New and Generic Drug Approvals

September 29, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Abilify Maintena Kit	aripiprazole	For Suspension, Extended Release;Intramuscular	Otsuka Pharm Co Ltd	Manufacturing Change or Addition
Alinia	nitazoxanide	For Suspension;Oral	Romark	Manufacturing Change or Addition
Clozaril	clozapine	Tablet;Oral	Novartis	Labeling Revision
Cortrosyn	cosyntropin	Injectable;Injection	Amphastar Pharms Inc	Manufacturing Change or Addition
Cozaar	losartan potassium	Tablet;Oral	Merck Sharp Dohme	Labeling Revision
Dextrose 5% In Plastic Container	dextrose	Injectable;Injection	B Braun	Manufacturing Change or Addition
Flo-Pred	prednisolone acetate	Suspension;Oral	Taro	Manufacturing Change or Addition
Fludarabine Phosphate	fludarabine phosphate	Injectable;Injection	Sandoz	Manufacturing Change or Addition
Hyzaar	hydrochlorothiazide; losartan potassium	Tablet;Oral	Merck Sharp Dohme	Labeling Revision
Lumigan	bimatoprost	Solution/Drops;Ophthalmic	Allergan	Labeling Revision
Lumigan	bimatoprost	Solution/Drops;Ophthalmic	Allergan	Labeling Revision
Nexterone	amiodarone hydrochloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Relistor	methylnaltrexone bromide	Injectable;Subcutaneous	Salix Pharms	Efficacy Supplement with Clinical Data to Support
Relistor	methylnaltrexone bromide	Solution;Subcutaneous	Salix Pharms	Efficacy Supplement with Clinical Data to Support
Skelaxin	metaxalone	Tablet;Oral	King Pharms	Manufacturing Change or Addition
Sodium Chloride 0.9% In Sterile Plastic Container	sodium chloride	Solution For Slush;Irrigation	Baxter Hlthcare	Manufacturing Change or Addition
Versacloz	clozapine	Suspension;Oral	Jazz Pharms Iii	Manufacturing Change or Addition
Voltaren	diclofenac sodium	Gel;Topical	Novartis	Manufacturing Change or Addition
Zingo	lidocaine hydrochloride	System;Intradermal	Powder Pharms	Manufacturing Change or Addition
Zovirax	acyclovir	Ointment;Topical	Valeant Bermuda	Manufacturing Change or Addition

Health Canada bans import of APIs and Finished Products from 3 sites in India...

Health Canada took action today to stop the import of health products from the following sites in India:

• Apotex Pharmachem India Pvt Ltd (APIPL)
• Apotex Research Private Limited (ARPL)
• IPCA Laboratories

The action applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA.
Health Canada has compiled an initial list of products affected by the Import ban.

CLICK HERE TO VIEW COMPLETE LIST OF PRODUCTS AFFECTED BY IMPORT BAN


The list will be updated periodically.

Certain medically necessary products may be excluded from the action on the condition they are tested by an independent third party before being released for use or sale. Independent testing against specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.

When data integrity issues were first identified at each of these sites by the U.S. Food and Drug Administration (FDA), Health Canada took action to protect the health and safety of Canadians. There is currently a voluntary quarantine on products from ARPL and IPCA. Products from APIPL have been undergoing additional testing, as required by Health Canada before being allowed on the Canadian market.

Health Canada continues to gather information about the situation at these three sites from trusted regulatory partners, including the FDA. Based on recent information, the Department has significant concerns with the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and APIs produced at these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognized good manufacturing practices (GMP), it is taking this additional precautionary step to keep these products off the Canadian market.

For more details CLICK HERE

MHRA Medical Device Alert : Neonatal and paediatric support devices: Gel-E Donut and Squishon 2 manufactured by Philips Healthcare (Children’s Medical Ventures)

Neonatal and paediatric support devices

Gel-E Donut, part numbers: 
92025-A, 92025-B, 92025-C

Squishon 2, part number: 
91033-2
All batches

Manufactured by Philips Healthcare (Children’s Medical Ventures)

 These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body.

For detailed information on recall alert CLICK HERE

USFDA: New and Generic Drug Approvals: 26 SEP 2014

New and Generic Drug Approvals

September 26, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acetic Acid 0.25% In Plastic Container	acetic acid, glacial	Solution;Irrigation, Urethral	Baxter Hlthcare	Manufacturing Change or Addition
Allopurinol	allopurinol	Tablet;Oral	Watson Labs	Manufacturing Change or Addition
Aminoacetic Acid 1.5% In Plastic Container	glycine	Solution;Irrigation	Baxter Hlthcare	Manufacturing Change or Addition
Cubicin	daptomycin	Injectable;Iv (Infusion)	Cubist	Manufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.2% In Plastic Container	dextrose; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.33% In Plastic Container	dextrose; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 15meq In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 20meq (K) In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 5meq In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Diclofenac Sodium	diclofenac sodium	Spray;Topical	Watson Labs	Tentative Approval
Diovan	valsartan	Tablet;Oral	Novartis	Labeling Revision
Elidel	pimecrolimus	Cream;Topical	Valeant Bermuda	Manufacturing Change or Addition
Firmagon	degarelix acetate	Powder;Subcutaneous	Ferring	Manufacturing Change or Addition
Hicon	sodium iodide i-131	Solution;Oral	Jubilant Draximage	Manufacturing Change or Addition
Lactated Ringer's In Plastic Container	calcium chloride; potassium chloride; sodium chloride; sodium lactate	Solution;Irrigation	Baxter Hlthcare	Manufacturing Change or Addition
Letairis	ambrisentan	Tablet;Oral	Gilead	Manufacturing Change or Addition
Linezolid	linezolid sodium chloride	Injectable;Injection	Hospira Inc	Tentative Approval
Lluvien	fluocinolone acetonide	Insert;Intravitreal	Alimera Sciences Inc	Approval
Loestrin 21 1.5/30	ethinyl estradiol; norethindrone acetate	Tablet;Oral-21	Warner Chilcott Llc	Manufacturing Change or Addition
Loestrin 21 1/20	ethinyl estradiol; norethindrone acetate	Tablet;Oral-21	Warner Chilcott Llc	Manufacturing Change or Addition
Loestrin Fe 1/20	ethinyl estradiol; norethindrone acetate	Tablet;Oral-28	Warner Chilcott	Manufacturing Change or Addition
Mekinist	trametinib dimethyl sulfoxide	Tablet;Oral	Glaxosmithkline Llc	Manufacturing Change or Addition
Mitigare	colchicine	Capsule;Oral	Hikma Pharms Llc	Approval
Namenda Xr	memantine hydrochloride	Capsule, Extended Release;Oral	Forest Labs	Labeling Revision
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container	dextrose; potassium chloride; sodium chloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Protonix Iv	pantoprazole sodium	Injectable;Iv (Infusion)	Wyeth Pharms Inc	Manufacturing Change or Addition
Qsymia	phentermine hydrochloride; topiramate	Capsule, Extended Release;Oral	Vivus	Labeling Revision
Qsymia	phentermine hydrochloride; topiramate	Capsule, Extended Release;Oral	Vivus	Supplement
Sodium Iodide I-131	sodium iodide i-131	Capsule;Oral	Jubilant Draximage	Manufacturing Change or Addition
Sterile Water For Injection In Plastic Container	sterile water for injection	Liquid;N/A	Baxter Hlthcare	Manufacturing Change or Addition
Sterile Water In Plastic Container	sterile water for irrigation	Liquid;Irrigation	Baxter Hlthcare	Manufacturing Change or Addition
Tagamet Hb	cimetidine	Tablet;Oral	Medtech Prods	Manufacturing Change or Addition
Xolair	omalizumab	Vial	Genentech	Efficacy Supplement with Clinical Data to Support
Zenpep	pancrelipase (amylase;lipase;protease)	Capsule, Delayed Release;Oral	Forest Labs Inc	Manufacturing Change or Addition
Zutripro	chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride	Solution;Oral	Cypress Pharm	Manufacturing Change or Addition
Zyrtec Allergy	cetirizine hydrochloride	Tablet;Oral	Mcneil Consumer	Manufacturing Change or Addition
Zyrtec Hives Relief	cetirizine hydrochloride	Tablet;Oral	Mcneil Consumer	Manufacturing Change or Addition

Strides Arcolab buys Shasun Pharma for $ 200 Million in an all-stock deal...

 

Webcast of Investor Meet - September 30, 2014