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Lannett Company Receives FDA Approval For Bethanechol Chloride Tablets USP, 5 Mg, 10 Mg, 25 Mg, And 50 Mg

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 31 Mar 2008 - 4:00 PDT

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Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Bethanechol Chloride Tablets in 5 mg, 10 mg, 25 mg, and 50 mg, the generic equivalent of Urecholine® Tablets marketed by Odyssey Pharmaceuticals, Inc.

According to Wolters Kluwer, total sales of generic Bethanechol Chloride Tablets were $60 million in 2007. Bethanechol Chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

"This approval represents an important new addition to our product portfolio and is the result of the hard work and dedication of our employees," said Arthur Bedrosian, president and chief executive officer of Lannett. "We will commence marketing our Bethanechol Chloride product, in the 5 mg, 10 mg, 25 mg, and 50 mg tablets, immediately."

Lannett Company

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications.

Lannett Company




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