Impax Receives FDA Approval For Generic Precose(R) Tablets, 25 Mg, 50 Mg And 100 Mg
Main Category: Pharma Industry / Biotech IndustryAlso Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 May 2009 - 4:00 PDT
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Impax Laboratories, Inc. (NASDAQ: IPXL) confirmed that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Precose® Tablets (acarbose), 25 mg, 50 mg and 100 mg strengths. Precose®, a Bayer HealthCare Pharmaceuticals product, is used in the management of type two diabetes mellitus.
The Company expects to launch all strengths in the fourth quarter of 2009, through Global Pharmaceuticals, Impax's generic division.
According to Wolters Kluwer Health, U.S. generic and brand sales for Acarbose 25 mg, 50 mg and 100 mg tablets were approximately $32 million for the 12 months ended March 2009.
Source
Impax Laboratories, Inc.
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16 Feb. 2012. <http://www.medicalnewstoday.com/releases/151116.php>
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http://www.medicalnewstoday.com/releases/151116.php.
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