Sigmapharm receives approval from FDA for Disulfiram Tablets

Bensalem, PA – March 28, 2011 – Sigmapharm Laboratories, LLC, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application for Disulfiram Tablets, USP 250 mg and 500 mg, the generic equivalent of Duramed Pharmaceuticals, Inc.’s reference listed drug Antabuse® Tablets, USP 250 mg and 500 mg.  The company believes that this is the first product approved by the FDA as the generic equivalent to Antabuse® Tablets.

Disulfiram is used as an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage.

“This is the first of several unique generic products that our company will be bringing to the market place within the next few months,” said Spiro Spireas, Ph.D., chairman and chief executive officer of Sigmapharm Laboratories.  “Our company intends to launch this product within the next few days.”