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Stock Market & Financial Investment News

News Breaks
October 12, 2012
14:19 EDTIPXLFDA delay of Impax's Rytary should have little impact on outlook, says Needham
After the FDA extended the PDUFA for Impax's Rytary by three months but didn't request any new clinical trials, Needham expects the move to little impact on the outlook of investors, who had expected the drug to be approved with little difficulty. The firm expects the drug to be approved but believes that peak sales will be below the company's guidance. Needham maintains a Hold rating on the shares.
News For IPXL From The Last 14 Days
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February 2, 2016
07:36 EDTIPXLImpax receives tentative FDA approval for generic Vytorin ANDA
Impax Laboratories announced that Impax has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for the generic version of the ezetimibe and simvastatin containing tablets, in 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg and 10 mg / 80 mg strengths. "We are pleased to receive tentative approval from the FDA for our generic version of Vytorin tablets," said Fred Wilkinson, President and CEO. "We will continue to work with the FDA to gain final approval upon the expiration of the U.S. patents and associated pediatric exclusivity on April 25, 2017, and are currently planning to be among the first generic products to market."

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