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 spokeswoman Dawn Plante said her company also ceased shipments, which had begun the day it received FDA approval. As for the restraining order, Plante said she expected it would be lifted following a March 6 hearing.
“The FDA determined that Fluticasone is bioequivalent to Flonase and we’re confident that once the court has the opportunity to review the facts, the suspension will be lifted,” Plante said.
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 does not comment on pending lawsuits, spokeswoman Laura Alvey said.
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.
Plante declined to disclose the price of Fluticasone Propionate Nasal Spray other than to say generics typically cost 30 percent to 80 percent less than their brand-name counterparts.
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On the Net: GlaxoSmithKline: http://www.gsk.com/
AP-ES-02-24-06 1442EST
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