Impax Laboratories, Inc, a technology based specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted approval of the company's Abbreviated New Drug Applications (ANDA) for generic versions of urecholine tablets (Bethanechol Chloride tablets USP) 5 mg, 10 mg, 25 mg, and 50 mg.
Odyssey Pharmaceuticals, Inc. markets urecholine for the treatment of acute post-operative and post partum non-obstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. Sales of both the branded and generic versions of urecholine tablets were approximately $33 million in the 12 months ended August 31, 2006, according to Wolters Kluwer Health.
"These ANDA approvals, our fourth through seventh this year, provide further validation of our strategy to develop niche generic pharmaceuticals," said Larry Hsu, Ph.D., Impax's president and chief executive Officer. "Our Global Pharmaceuticals division will begin marketing our generic urecholine soon."