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.

View drug information on FLOMAX.


Article adapted by Medical News Today from original press release.
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Impax Laboratories, Inc.. "Impax Laboratories Receives Tentative FDA Approval For Generic FLOMAX(R) 0.4mg Capsules." Medical News Today. MediLexicon, Intl., 7 Oct. 2009. Web.
13 Feb. 2012. <http://www.medicalnewstoday.com/releases/166396.php>

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Impax Laboratories, Inc.. (2009, October 7). "Impax Laboratories Receives Tentative FDA Approval For Generic FLOMAX(R) 0.4mg Capsules." Medical News Today. Retrieved from
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