FDA grants Impax tentative approval of ANDA for FLOMAX generic version

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Impax Laboratories, Inc.Oct 5 2009

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Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. Boehringer Ingelheim Pharmaceuticals, Inc. markets FLOMAX® for the functional symptoms of benign prostatic hyperplasia.

According to Wolters Kluwer Health, U.S. sales of Flomax® 0.4mg capsules were approximately $1.9 billion for the 12 months ended August 31, 2009.

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Impax Laboratories, Inc.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Benign Prostatic Hyperplasia, Drug Delivery, Food, Hyperplasia, New Drug Application, Pharmaceuticals

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