HAYWARD, Calif.--(BUSINESS WIRE)--March 2, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application for a generic version of Dantrium(R) (Dantrolene Sodium) 25, 50 and 100 mg Capsules. Proctor and Gamble Pharmaceuticals markets Dantrium for the treatment of spasticity in stroke, multiple sclerosis, cerebral palsy and spinal cord injury. U.S. sales of Dantrium 25, 50 and 100 mg Capsules were approximately $14 million in the 12 months ended December 31, 2004, according to NDCHealth. IMPAX's Global Pharmaceuticals division intends to begin marketing this product immediately.
"This is our second approval, and first final approval, this year," said Larry Hsu, Ph.D., IMPAX's President. "We are very pleased to see that our efforts are culminating in new product approvals. As the first generic version of Dantrium approved by the FDA, this product should offer both patients and payors a cost-effective alternative to the brand."
Source: Impax Laboratories, Inc.