CORAL SPRINGS, Fla., Dec. 28 /PRNewswire/ -- Boca Pharmacal, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Kenwood Therapeutics Pamine® (Methscopolamine Bromide) Tablets, 2.5 mg and Pamine® Forte (Methscopolamine Bromide) Tablets 5 mg. The Company plans to launch its product immediately.
Methscopolamine Bromide 2.5 mg and Methscopolamine Bromide 5 mg are indicated for the treatment of adjunctive therapy for the treatment of peptic ulcer.
Robert J Edwards Jr., Chairman and CEO commented that, "This is an exciting time for Boca Pharmacal. Methscopolamine Bromide is the first of many approvals we expect over the next twelve months. Our mission is to offer lower volume items that may have been overlooked by some of the larger generic companies. We do not plan to market the next blockbuster item coming off patent; but instead focus on delivering niche type products."
Founded in 1998 Coral Springs, FL based Boca Pharmacal manufactures, develops and distributes a wide variety of generic drugs.
Source: Boca Pharmacal, Inc.