FDA approves Bethanechol chloride using new application method

PATERSON, N.J. The Food and Drug Administration has approved Amneal’s application to manufacture Bethanechol chloride tablets in 5 mg, 10 mg, 25 mg and 50 mg strengths. Bethanechol is used to treat urinary retention resulting from general anesthetic or diabetic neuropathy of the bladder, or to treat gastrointestinal atony.

Amneal is one of the very first companies to submit an application in the FDA’s new, optional eCTD/QBR/QOS format. This new 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.

Amneal will begin shipping Bethanechol in the 25 mg strength as of Jan. 4, 2008, with the other three strengths beginning in February 2008.