GlaxoSmithKline is asking FDA for a three-day stay of action once the agency notifies the company of its decision to grant final approval for generic versions of its nasal steroids Flonase and Beconase AQ .

"GSK seeks the opportunity to initiate judicial review of any such approvals before generic products have entered the marketplace" for Flonase (fluticasone) and Beconase AQ (beclomethasone), a March 25 ¹ petition for stay of action states.

"A stay of action of three business days would allow GSK to seek temporary relief from a court with the status quo intact."

"Sound public policy grounds support the entry of a brief administrative stay to allow GSK to consider and pursue its right to judicial review without being undermined by unnecessary shifts in underlying circumstances," the petition states.

If the generics are approved and allowed to launch, it will be more difficult for GSK to reverse the approval decision and have the products withdrawn than address the issue prior to launch.

"Reviewing courts are usually loathe to force affirmative changes in the status quo, pending full adjudication....However, absent the requested stay of action, GSK will be forced to ask a reviewing court to do the extraordinary: pull the generic products from the marketplace," the petition states.

"A court may understandably be reluctant to go that far, particularly given the significance of the 'balance of harms' factor in the preliminary relief analysis."

The new petition may suggest that GSK anticipates approval of the generics shortly. Ivax previously predicted approval of Flonase generics would occur in 2004 (² [A#00660230005], p. 10).

Neither products have patent protection; Flonase's pediatric exclusivity expired in May 2004 and Beconase's exclusivity expired 10 years ago.

GSK submitted a citizen's petition in May 2004 asking FDA to revise and finalize an April 2003 draft guidance for generic nasal sprays prior to approving generic versions of the drugs.

The guidance was to set forth a valid methodology for assessing the bioequivalence of nasal spray products.

In November, GSK submitted a second citizen petition to ensure that generic versions of Flonase meet the same "high standard of quality" as the branded product. FDA has not responded to either petition, the company said.

Under FDA regulations, the agency may enter a stay when four conditions are met: (1) the petitioner will otherwise suffer irreparable injury; (2) the petitioner's case is not frivolous and is being pursued in good faith; (3) the petitioner has demonstrated sound public policy grounds supporting the stay; and (4) the delay resulting from the stay is not outweighed by public health or other public interests.

GSK says that irreparable injury would occur from generic entry and the subsequent erosion of Flonase sales. Generic marketing could also give rise to irreparable injury, the company argued.

"Even if ANDA approvals are subsequently set aside, the monetary losses to GSK from improvident marketing could never be recouped, giving rise to irreparable injury," the petition states.

The company maintains that the petition is submitted in good faith based on the validity of the issues raised in its two previous citizen petitions.

"In no sense are the issues 'frivolous,' and in no sense is GSK raising these issues without due cause," the petition states.

The company further asserted that its requested three-day stay demonstrates sound public policy grounds.

"A brief three business day stay to prevent a compound harm from unfolding, while GSK pursues judicial review as warranted, is wholly consistent with public policy," the petition states.

The petition is in the public interest, GSK said, as "the public has a substantial interest in ensuring the legal and scientific integrity" of any Flonase or Beconase generic. GSK's long-term defense of the Flonase franchise includes a planned OTC switch.

GSK Wary Of Flonase Generic Surprise; Asks FDA For Notice

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