Impax responds to recinded FDA acceptance of Impax’s generic Opana ER
HAYWARD, Calif. Impax Laboratories has responded to the Food and Drug Administration following the agency’s acceptance withdrawal for the company’s drug application for a generic version of Opana ER. Opana ER is a narcotic painkiller whose generic name is oxymorphone hydrochloride.
The FDA originally accepted Impax’s application for filing but subsequently rescinded that acceptance. Impax said it believes it has submitted the information the agency needs to reaccept the application.
The company said its original application met all requirements for acceptance and that the agency’s withdrawal was “inappropriate.” It wants the FDA to reinstate its original application filing date.
Endo Pharmaceuticals and Penwest Pharmaceuticals sued Impax last month after receiving notice of the company’s application for Opana ER containing a Paragraph IV certification. Impax announced publicly that the FDA had rescinded acceptance of its application after sending out the Paragraph IV notice, according to the Nov. 15 complaint, filed in the U.S. District Court for the District of Delaware.
According to Wolters Kluwer Health, U.S. sales of Opana ER tablets were approximately $48.8 million in the 12 months ended Sept. 30, 2007.
FDA approves Teva’s generic Trileptal
The Food and Drug Administration has granted final approval to Teva for its application to market a generic version of Trileptal, by Novartis, for the treatment of epilepsy.
The generic, oxcarbazepine, will be available in 150, 300 and 600 mg tablets. Teva will begin shipping the drug in the near future.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
The brand product had annual sales of approximately $690 million in the United States for the twelve months ended Sept. 30, 2007, based on IMS sales data.
Biogen’s lack of buyer interest triggers stock price dive
CAMBRIDGE, Mass. Biogen has reported that after two months of looking for a potential buyer, it has turned up no serious offers, which led to a 27 percent drop in the company’s shares, according to the Wall Street Journal.
Biogen said in a statement that it “did not receive any definitive offers to purchase the company” and would abandon exploration of a sale. Within a few minutes of the announcement, Biogen lost nine months of increasing business by buyout rumors.
Pharmaceutical firms may have been discouraged by Biogen’s high price—its market value had grown to $25 billion after the company announced its intention to sell. Last month, Sanofi-Aventis’ chief executive called Biogen’s price “a little high.”
Biogen has three main drugs on the market—Avonex and Tysabri for multiple sclerosis and Rituxan for cancer and rheumatoid arthritis. Some analysts said uncertainties about the future of the drugs were too great for buyers. Tysabri has been linked to a rare brain disorder, prompting close regulatory scrutiny.
The stock price fell from $75.88 to $55.50 on the Nasdaq Stock Market.