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

Friday, November 30, 2007 General News J E 4
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PATERSON, N.J., Nov. 29 Amneal Pharmaceuticals is pleasedto announce that it received US FDA approval to manufacture BethanecholChloride Tablets, USP in strengths of 5mg, 10mg, 25mg and 50 mg, effectiveNovember 21, 2007. Bethanechol HCl is an AA-Rated, therapeutically equivalentalternative to Urecholine(R) (a trademark of Barr Laboratories).

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

Amneal will begin shipping Bethanechol in the 25mg strength as of January4, 2008 with the other three strengths beginning in February 2008. Amneal'sBethanechol is expected to be available through wholesalers-distributors aswell as directly to customers.

Amneal Pharmaceuticals LLC, headquartered in Paterson, NJ, is a USA-basedfirm that develops, manufacturers and distributes generic pharmaceuticalproducts regulated and approved by the US FDA. Positioned as "Generic's NewGeneration," the company utilizes diverse R&D and manufacturing expertise toconceive breakthrough developments with lasting impact. Vigorous ANDA growthand broad product acquisitions are key features of Amneal's strategic growthplan, as is the company's commitment to building deep relationships with itscustomer base. Amneal delivers superior service levels, quality products, anddynamic value throughout the pharmaceutical industry.

SOURCE Amneal Pharmaceuticals LLC
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