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Tag: usfda

You Searched For "usfda"
USFDA accepts review application from Valeant Pharmaceuticals International and Progenics Pharmaceuticals

USFDA accepts review application from Valeant Pharmaceuticals International and Progenics Pharmaceuticals

Pooja9 Sept 2015 5:14 PM IST
USFDA has in principal given nod for the tablets-based treatment of opioid-induced constipation by accepting RELISTOR (methylnaltrexone bromide)...
Aurobindo Pharma gets approval from USFDA for hypertension drugs

Aurobindo Pharma gets approval from USFDA for hypertension drugs

Pooja5 Sept 2015 3:01 PM IST
Aurobindo Pharma’s hypertension drug, the generic Telmisartan tablets in the strengths of 20 mg, 40 mg, and 80 mg, has got an approval from the...
Roche wins breakthrough designation from USFDA for haemoplilia medicine

Roche wins breakthrough designation from USFDA for haemoplilia medicine

Pooja5 Sept 2015 2:54 PM IST
The Swiss drugmaker Roche has reported that it US based Genentech unit's ACE910 secured the fast-track designation from USFDA for an experimental...
Hypertension drugs recalled by Dr Reddys Laboratories

Hypertension drugs recalled by Dr Reddy's Laboratories

Meghna A Singhania5 Sept 2015 12:35 PM IST
Dr Reddy's Laboratories will recall over 55,000 bottles of Amlodipine besylate and Atorvastatin calcium tablets, used to treat high blood pressure and...
Sun Pharma, Wockhardt initiate voluntary drug recall in US market

Sun Pharma, Wockhardt initiate voluntary drug recall in US market

Pooja31 Aug 2015 10:26 AM IST
Sun Pharma recalls Bupropion Hydrochloride Extended-release Tablets USP (SR) used as an anti-depressant Sun Pharma has reportedly initiated a...
USFDA approves Repatha to treat certain patients with high cholesterol

USFDA approves Repatha to treat certain patients with high cholesterol

Meghna A Singhania30 Aug 2015 11:34 AM IST
The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density...
Aurobindo Pharma gets USFDA nod for generic osteoporosis drug

Aurobindo Pharma gets USFDA nod for generic osteoporosis drug

Meghna A Singhania30 Aug 2015 11:17 AM IST
New Delhi, Aug 29 : Aurobindo Pharma today said it has received approval from the US FDA to manufacture and market its generic version of Eli Lilly's...
FDA warns of severe joint pain risk with DPP-4 diabetes drugs

FDA warns of severe joint pain risk with DPP-4 diabetes drugs

Meghna A Singhania29 Aug 2015 11:09 AM IST
A class of diabetes drugs that include Merck & Co Inc's Januvia has been linked with severe joint pain, the U.S. Food and Drug Administration said...
Lupin gets approval from USFDA for ulcer drug

Lupin gets approval from USFDA for ulcer drug

Pooja29 Aug 2015 11:05 AM IST
Lupin has received an approval from USFDA to market a generic drug in the US to treat ulcerDrug firm Lupin has received a nod from US Food and Drug...
Suffix to distinguish biosimilars now

Suffix to distinguish biosimilars now

Pooja28 Aug 2015 1:04 PM IST
Copies of biologic products knows as biosimilars will now have suffix to their names to distinguish them from their branded counterparts says...
USFDA approves Type 2 diabetes drug from Boehringer Ingelheim Pharmaceuticals and Eli Lilly

USFDA approves Type 2 diabetes drug from Boehringer Ingelheim Pharmaceuticals and Eli Lilly

Pooja28 Aug 2015 10:29 AM IST
USFDA has approved a drug from Boehringer Ingelheim Pharmaceuticals (BIPI) and Eli Lilly and Company to help control blood glucose in people with Type...
USFDA approves use of Promacta for use in children aged 1 and older

USFDA approves use of Promacta for use in children aged 1 and older

Meghna A Singhania25 Aug 2015 5:07 PM IST
FDA expands use of Novartis drug Promacta ® to include treatment of children ages 1 and older with chronic immune thrombocytopenia- New oral...
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