March 03, 2006
GlaxoSmithKline temporarily blocks sale of generic Flonase
GlaxoSmithKline obtained a temporary restraining order blocking the shipment and sales of the recently FDA-approved generic competitor to its Flonase nasal spray for allergies, the Associated Press reported.
A federal judge in Baltimore granted the 10-day order late Thursday, a GlaxoSmithKline spokesperson told the news agency.
The order applies to both Roxane Laboratories’ fluticasone propionate nasal spray, which the FDA approved Wednesday, and Par Pharmaceutical Companies’ own generic version of Flonase, which GlaxoSmithKline authorized.
Par said in a statement that it would comply with the order.
The court order, which expires March 6, comes one day after GlaxoSmithKline sued the FDA, alleging the agency failed to follow its own regulations in approving the Flonase generic and failed to apply the same quality standards.
GSK made the same arguments in petitions it filed with the FDA. The FDA rejected those petitions.
GlaxoSmithKline sold nearly $1.2 billion in Flonase worldwide last year. The US market accounted for $921 million of those sales.
Roxane Laboratories is a Columbus, OH–based subsidiary of Germany’s Boehringer Ingelheim group.