Barr Pharmaceuticals (BRL) Receives FDA Approval for Generic Razadyne

September 16, 2008 4:02 PM EDT

Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne® ER (galantamine hydrobromide extended release capsules), eq. to 8 mg, 16 mg and 24 mg. Barr also announced that it is the first company to file an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) containing a Paragraph IV certification for a generic version of Razadyne ER capsules, and therefore is entitled to 180-days of marketing exclusivity, as provided for under the Hatch Waxman Act. The Company intends to launch its product shortly.

Barr filed its ANDA with the FDA containing a Paragraph IV certification for the 8 mg eq. capsule strength of Razadyne ER on March 1, 2006. Barr amended its ANDA on March 10, 2006 to include the 16 mg eq. and 24 mg eq. capsule strengths in its filing. Following receipt of the notice from the FDA that Barr's ANDA was accepted for filing, Barr notified the New Drug Application (NDA) holder and patent owner.[SM]

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