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FDA Roundup: Aurobindo Pharma Ltd.

FDA ROUNDUP: Aurobindo Pharma Ltd. (Hyderabad, India) received approval for ceftazidime injections in single- and bulk-dosage forms. Ceftazidime injections, used to cure infections of various tissues, are the generic equivalent of GlaxoSmithKline's branded drug, Fortaz, the company said in a statement. The injections have a market of about $30 million in the U.S., it said.

Elsewhere, Perrigo Co. (Allegan MI) won approval for a generic over-the-counter version of Johnson & Johnson's vaginal cream Monistat. Perrigo said it will start shipping the miconazole product immediately. It said Monistat has annual retail sales of about $90 million. Perrigo was the first to file an application to make a generic version of the yeast-infection treatment and the resulting patent litigation filed by Johnson & Johnson was previously dismissed. Perrigo's approval includes six months of generic marketing exclusivity. Shares of Perrigo closed the week down $2.43, or 4%, at $56.98. The stock has traded between $25.47 and $64.66 over the last 52 weeks.

And Teva Pharmaceutical Industries Ltd. (Petah Tikva, Israel) was cleared to sell a generic version of Galderma's acne treatment Differin. Teva said the product has annual sales of about $91 million in the U.S.

However, AstraZeneca Plc (London), the U.K.'s second-largest drugmaker, failed to get FDA approval for an experimental treatment to prevent ulcers. The FDA issued a response letter to the application for Axanum, AstraZeneca said. The medicine combines aspirin and esomeprazole, the main ingredient in the company's best-selling ulcer treatment Nexium. AstraZeneca sought permission to sell it to prevent ulcers of the stomach and duodenum. The company was also denied permission to broaden the use of Nexium. The FDA issues complete response letters when its review of a filing is completed and it can't approve the drug in its present form. AstraZeneca said it's evaluating the letters and holding discussions with the FDA to determine its next course of action. The company, which submitted both applications on April 30 last year, said it will respond to the regulator's request for more information.

In other news, Eisai Co. (Tokyo, Japan), maker of the world's best-selling drug for Alzheimer's, will get a priority review of its new treatment for advanced breast cancer, reducing market approval time by four months. The FDA will decide whether to approve eribulin by Sept. 30, Eisai said in a statement. The treatment was given a six-month review instead of the 10 months generally taken by the FDA, said Takeshi Shimizu, a spokesman for Eisai. Eribulin would be Eisai's first original drug for more than a decade in the U.S. The Japanese drugmaker is focusing on cancer treatments in anticipation of a decline in sales when its Aricept Alzheimer's drug loses U.S. patent protection in November. The FDA grants priority review to drugs intended to treat conditions where no satisfactory alternative exists or when the treatment offers "significant improvement compared to marketed products," according to the Eisai statement.
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Title Annotation:CORPORATE
Date:Jun 7, 2010
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