Amneal Receives FDA Approval For Bethanechol Chloride Tablets

Armen Hareyan's picture
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Amneal Pharmaceuticals has received US FDA approval to manufactureBethanechol 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 BarrLaboratories).

The Bethanechol approval represents abreakthrough for Amneal, who is one of the very first companies to submit anANDA in the FDA's new, optional eCTD/QBR/QOS format. This application methodresulted in a significantly more efficient approval evaluation process,dramatically reducing anticipated approval time.

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Amneal's Bethanechol eCTD applicationwas approved just 10 months and 10 days after its January 2007 applicationdate. All of Amneal's ANDAs since Bethanechol are being filed using the eCTDformat.

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

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