GlaxoSmithKline blocks sales of generic competitor to its Flonase nasal spray

Friday, February 24th 2006, 10:25 am

By: News On 6

WASHINGTON (AP) _ GlaxoSmithKline said Friday it obtained a temporary restraining order blocking the shipment and sales of a recently FDA-approved generic competitor to its Flonase nasal spray for allergies.

A federal judge in Baltimore granted the 10-day order late Thursday, GlaxoSmithKline spokeswoman Mary Anne Rhyne said.

The order applies to both Roxane Laboratories Inc.'s Fluticasone Propionate Nasal Spray, which the Food and Drug Administration approved Wednesday, and Par Pharmaceutical Companies Inc.'s own generic version of Flonase, which GlaxoSmithKline authorized. Pharmaceutical companies often license generic versions of their own drugs to undercut generic competitors just as they come onto the market with their own versions of a drug.

Par said in a statement that it would comply with the order. Roxane Laboratories did not immediately return a call seeking comment.

The court order, which expires March 6, comes one day after GlaxoSmithKline sued the FDA.

GlaxoSmithKline alleges the FDA failed to follow its own regulations in approving the Flonase generic and failed to apply the same quality standards, Rhyne said. The company made the same arguments in petitions it filed with the FDA. The FDA rejected those petitions.

The FDA did not immediately return a message seeking comment.

GlaxoSmithKline sold nearly $1.2 billion in Flonase worldwide last year. The U.S. market accounted for $921 million of those sales, Rhyne said.

GlaxoSmithKline is based in the United Kingdom. Roxane Laboratories Inc. is a Columbus, Ohio-based subsidiary of Germany's Boehringer Ingelheim group.