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PRX to add generic Flonase to its arsenal?
I sure hope so! Go PRX!!! (It's FINALLY above my double-down price of $34 now)
UPDATE 2-US FDA ok's generic version of Glaxo allergy spray
Wed Feb 22, 2006 5:25 PM ET
(Recasts, adds details, Glaxo comment)
By Susan Heavey
WASHINGTON, Feb 22 (Reuters) - The first generic version of GlaxoSmithKline's (GSK.L: Quote, Profile, Research) (GSK.N: Quote, Profile, Research) widely-used allergy spray Flonase won U.S. approval on Wednesday, but the British drugmaker said it might take legal action against the U.S. Food and Drug Administration.
Flonase, which brings in more than $1 billion in U.S. annual sales, helps treat stuffy and runny noses in both adults and children at least 4 years old. The FDA said its action would help consumers save millions of dollars.
"We believe that giving consumers a choice of safe, effective and reasonably-priced alternatives is extremely important to the economy and well-being of the American public," Gary Buehler, director of FDA's Office of Generic Drugs, told reporters.
Britain-based Glaxo's last patent for the nasal spray drug expired in November 2005, the FDA said. Privately-held Boehringer Ingelheim Corp. subsidiary Roxane Laboratories will market the new generic version.
Glaxo spokeswoman Mary Anne Rhyne said the company might take legal action, but was still reviewing the FDA's decision.
"We're seriously studying possible next steps... legal action," she said, adding that Glaxo hoped to make its decision "pretty quickly" before the generic version launched.
Shares of generic drugmaker Par Pharmaceutical (PRX.N: Quote, Profile, Research) surged about 8 percent after the FDA approval, closing at $36.31 a share.
Par has said it has an unspecified product in its pipeline, which Wall Street has long assumed to be a generic version of Flonase. However, some analysts declined to comment on the record on the stock move, and the company was not immediately available for comment.
Ivax Corp., which was acquired by Teva Pharmaceutical Industries Ltd. (TEVA.O: Quote, Profile, Research) in January, has said it is pursuing a generic version of Flonase. Teva shares closed up 2.63 percent at $42.08 on the Nasdaq.
Prudential Equity Group analyst Tim Anderson said the FDA's decision came as a surprise, since generic drugmakers had been trying to win approval for years. "We have not been modeling generic Flonase into our 2006 forecasts," he said in a research note.
FDA's Buehler said the agency could not act until Flonase's last patent expired last November.
The FDA said it received five petitions, including three from Glaxo, questioning the agency's criteria for approving generic nasal sprays. Glaxo had asked for industry guidelines to be issued first, a regulatory process that can take years or even decades.
But the agency stressed the generic sprays were just as good as Glaxo's brand name one.
"Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use," the FDA said.
Shares of Glaxo closed down 3 cents on the New York Stock Exchange at $50.99. (Additional reporting by Lewis Krauskopf in New York)
I sure hope so! Go PRX!!! (It's FINALLY above my double-down price of $34 now)
UPDATE 2-US FDA ok's generic version of Glaxo allergy spray
Wed Feb 22, 2006 5:25 PM ET
(Recasts, adds details, Glaxo comment)
By Susan Heavey
WASHINGTON, Feb 22 (Reuters) - The first generic version of GlaxoSmithKline's (GSK.L: Quote, Profile, Research) (GSK.N: Quote, Profile, Research) widely-used allergy spray Flonase won U.S. approval on Wednesday, but the British drugmaker said it might take legal action against the U.S. Food and Drug Administration.
Flonase, which brings in more than $1 billion in U.S. annual sales, helps treat stuffy and runny noses in both adults and children at least 4 years old. The FDA said its action would help consumers save millions of dollars.
"We believe that giving consumers a choice of safe, effective and reasonably-priced alternatives is extremely important to the economy and well-being of the American public," Gary Buehler, director of FDA's Office of Generic Drugs, told reporters.
Britain-based Glaxo's last patent for the nasal spray drug expired in November 2005, the FDA said. Privately-held Boehringer Ingelheim Corp. subsidiary Roxane Laboratories will market the new generic version.
Glaxo spokeswoman Mary Anne Rhyne said the company might take legal action, but was still reviewing the FDA's decision.
"We're seriously studying possible next steps... legal action," she said, adding that Glaxo hoped to make its decision "pretty quickly" before the generic version launched.
Shares of generic drugmaker Par Pharmaceutical (PRX.N: Quote, Profile, Research) surged about 8 percent after the FDA approval, closing at $36.31 a share.
Par has said it has an unspecified product in its pipeline, which Wall Street has long assumed to be a generic version of Flonase. However, some analysts declined to comment on the record on the stock move, and the company was not immediately available for comment.
Ivax Corp., which was acquired by Teva Pharmaceutical Industries Ltd. (TEVA.O: Quote, Profile, Research) in January, has said it is pursuing a generic version of Flonase. Teva shares closed up 2.63 percent at $42.08 on the Nasdaq.
Prudential Equity Group analyst Tim Anderson said the FDA's decision came as a surprise, since generic drugmakers had been trying to win approval for years. "We have not been modeling generic Flonase into our 2006 forecasts," he said in a research note.
FDA's Buehler said the agency could not act until Flonase's last patent expired last November.
The FDA said it received five petitions, including three from Glaxo, questioning the agency's criteria for approving generic nasal sprays. Glaxo had asked for industry guidelines to be issued first, a regulatory process that can take years or even decades.
But the agency stressed the generic sprays were just as good as Glaxo's brand name one.
"Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use," the FDA said.
Shares of Glaxo closed down 3 cents on the New York Stock Exchange at $50.99. (Additional reporting by Lewis Krauskopf in New York)
). I'd like to do that again. I'll look into this one today.
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