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Amneal receives FDA approval for bethanechol chloride tablets

Amneal Pharmaceuticals has received FDA approval to manufacture bethanechol chloride tablets, in strengths of 5mg, 10mg, 25mg and 50 mg for the treatment of urinary incontinence.

Bethanechol chloride is an AA-rated, therapeutically equivalent alternative to Urecholine, a trademark drug of Barr Laboratories.

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.