FDA obtains permanent injunction against Neilgen, Advent

ROCKVILLE, Md. In a further development in the Food and Drug Administration’s regulatory actions against companies manufacturing and distributing unapproved drugs, the agency has obtained a permanent injunction against two companies barring them from doing so.

The FDA obtained the injunction against Westminster, Md.-based Neilgen Pharmaceuticals, which does business as Unigen Pharmaceuticals, and East Windsor, N.J.-based Advent Pharmaceuticals, contract manufacturers and distributors of a total of more than 50 unapproved drugs, mostly prescription cough and cold medicines.

The agency said the companies signed a consent decree, entered by U.S. District Court of Maryland chief judge Benson Legg, that orders them to destroy their existing drug supply and not manufacture or distribute any new drugs without FDA approval. The decree also authorizes the FDA to take action in case of future violations and subjects the companies to damages of $1,000 for each violation.

The FDA sought the injunction after the companies refused to comply with previous warnings and continued manufacturing drugs in violation of federal law. The FDA said multiple inspections found several violations of current Good Manufacturing Practice requirements for drugs and that the companies failed to adequately respond to the FDA’s inspection findings.

“To protect the American public, companies that continue to market unapproved drugs must be required to cease that illegal activity,” FDA Center for Drug Evaluation and Research director Janet Woodcock stated. “It is critical that only drugs that are safe, effective and manufactured in accordance with good manufacturing practices be allowed into the U.S. marketplace.”