(By Balaseshan) Mylan Inc. (NASDAQ: MYL), a pharmaceutical company, said its subsidiary launched the generic version of Pfizer Inc.'s (NYSE: PFE) Revatio drug to treat pulmonary arterial hypertension in adults.
Mylan Laboratories Ltd. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sildenafil Citrate Tablets, 20 mg. Mylan has begun shipping this product.
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This product is the generic version of Pfizer's Revatio, which is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening.
Revatio Tablets, 20 mg, had U.S. sales of approximately $338.7 million for the 12 months ending September 30, 2012, according to IMS Health. Currently, Mylan has 172 ANDAs pending FDA approval representing $79.5 billion in annual sales.
On September 28, Mylan Pharmaceuticals Inc. has received final approval from FDA for its Abbreviated New Drug Application (ANDA) for Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg, the generic version of Sanofi's Avapro.
The company also received final approval from the FDA for its ANDA for Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5 mg, the generic version of Sanofi's Avalide.
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Irbesartan Tablets are indicated for the treatment of hypertension and in patients with type 2 diabetic nephropathy, and Irbesartan and Hydrochlorothiazide Tablets are indicated for hypertension in patients not adequately controlled with a single drug, and as initial therapy in patients likely to need multiple drugs to achieve blood pressure control.
MYL closed Monday's regular session at $26.03. The stock has been trading between $17.22 and $26.55 for the past 52 weeks.