FDA APPROVES IMPAX'S GENERIC URECHOLINE

Impax Laboratories announced that the FDA has granted approval of the company's abbreviated new drug applications (ANDA) for generic versions of Urecholine Tablets (bethanechol chloride tablets) 5, 10, 25 and 50 mg.

Odyssey Pharmaceuticals markets Urecholine for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. Sales of both the branded and generic versions of bethanechol chloride were approximately $33 million in the 12 months ending August, Impax said, citing Wolters Kluwer Health.

This is Impax's fourth ANDA approval this year. Impax markets its generic products through its Global Pharmaceuticals division.