Impax Laboratories Receives Tentative FDA Approval For Generic FLOMAX(R) 0.4mg Capsules

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Oct 2009 - 0:00 PDT

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Impax Laboratories, Inc. (NASDAQ: IPXL) 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.

Source
Impax Laboratories, Inc.