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Amneal Receives FDA Approval for Bethanechol Chloride Tablets, USP Using New Expedited FDA Approval Process

PATERSON, N.J., Nov. 29 /PRNewswire/ -- Amneal Pharmaceuticals is pleased to announce that it received US FDA approval to manufacture Bethanechol Chloride Tablets, USP in strengths of 5mg, 10mg, 25mg and 50 mg, effective November 21, 2007. Bethanechol HCl is an AA-Rated, therapeutically equivalent alternative to Urecholine(R) (a trademark of Barr Laboratories).

The Bethanechol approval represents a breakthrough for Amneal, who is one of the very first companies to submit an ANDA in the FDA's new, optional eCTD/QBR/QOS format. This application method resulted in a significantly more efficient approval evaluation process, dramatically reducing anticipated approval time. Amneal's Bethanechol eCTD application was approved just 10 months and 10 days after its January 2007 application date. All of Amneal's ANDAs since Bethanechol are being filed using the eCTD format.

Amneal will begin shipping Bethanechol in the 25mg strength as of January 4, 2008 with the other three strengths beginning in February 2008. Amneal's Bethanechol is expected to be available through wholesalers-distributors as well as directly to customers.

Amneal Pharmaceuticals LLC, headquartered in Paterson, NJ, is a USA-based firm that develops, manufacturers and distributes generic pharmaceutical products regulated and approved by the US FDA. Positioned as "Generic's New Generation," the company utilizes diverse R&D and manufacturing expertise to conceive breakthrough developments with lasting impact. Vigorous ANDA growth and broad product acquisitions are key features of Amneal's strategic growth plan, as is the company's commitment to building deep relationships with its customer base. Amneal delivers superior service levels, quality products, and dynamic value throughout the pharmaceutical industry.

SOURCE Amneal Pharmaceuticals LLC
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