Parkedale Pharmaceuticals, FDA Meet to Discuss Fluogen Compliance

Parkedale Pharmaceuticals Inc., a wholly-owned subsidiary of King Pharmaceuticals Inc. (Bristol, TN), met with the U.S. Food and Drug Administration (FDA) last week to discuss the status of the company's compliance program for Fluogen (influenza virus vaccine, trivalent, types A and B). The meeting was held to discuss Parkedale's plans and specific timelines for completion of corrective actions.

On March 10, the FDA notified Parkedale that it needed to implement corrective measures related to its manufacture of Fluogen. Since then, Parkedale has communicated regularly with the FDA on the corrective actions. Last week's meeting was held in response to an FDA request for information and an outline of unresolved compliance issues. Once it determines that Parkedale is in substantial compliance with the current good manufacturing practice regulations, the FDA will authorize distribution of Fluogen.

Following the meeting, the FDA stated that it is pleased and encouraged by Parkedale's efforts and progress to date. FDA officials will continue to work closely with Parkedale in an attempt to resolve any remaining issues.

King manufactures, markets, and sells primarily branded prescription pharmaceutical products. The company acquires products made available by cost-containment initiatives and consolidation among large global pharmaceutical companies, and then seeks to increase their sales by focused promotion and marketing and through product life cycle management.

For more information: King Pharmaceuticals Inc., 501 5th St., Bristol, TN 37620. Tel: 423-989-8000. Fax: 423-274-8634.

Edited by Jim Pomager