Supplier News Breaks Archives
Mylan, Watson to ship antihypertensive generics
October 15th, 2010
NEW YORK – Mylan Inc. and Watson Pharmaceuticals Inc. have received approval from the Food and Drug Administration for generic versions of medications for hypertension.
Mylan said Friday that its Mylan Pharmaceuticals Inc. subsidiary obtained clearance for the generic versions of Hyzaar Tablets (50 mg/12.5 mg and 100 mg/25 mg) and Cozaar Tablets (25 mg, 50 mg and 100 mg), both indicated for the treatment of high blood pressure.
Merck & Co.'s Hyzaar is known generically as Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets, and Merck Research Laboratories' Cozaar is known generically as Losartan Potassium Tablets, according to Mylan.
Losartan Potassium and HCTZ Tablets, 50 mg/12.5 mg and 100 mg/25 mg, had U.S. sales of about $570 million and Losartan Potassium Tablets had U.S. sales of approximately $940 million for the 12 months ended June 30, according to IMS Health data cited by Mylan. Both products are available for immediate shipment, the company said.
Mylan Pharmaceuticals received final FDA approval and launched the 100 mg/12.5 mg strength of Losartan Potassium and HCTZ Tablets in April, Mylan added.
Also on Friday, Watson said its Watson Laboratories Inc. gain final approval from the FDA for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg and 5/10mg capsules, the generic equivalent to Novartis' Lotrel capsules, indicated to prevent and treat high blood pressure.
Watson reported that the Abbreviated New Drug Application (ANDA) for the medication was acquired as part of the company's acquisition of Arrow Group. Plans call for the product to start shipping immediately.
According to Watson, Lotrel capsules and generic equivalents had total U.S. sales of about $1.05 Billion for the 12 months ended June 30, based on IMS Health figures.