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News Breaks
June 20, 2014
08:03 EDTIG, IPXLIGI Laboratories completes seventh ANDA filing under joint agreement with Impax
IGI Laboratories (IG) announced it has submitted its seventh abbreviated new drug application in 2014 to the FDA. The seventh ANDA submission was in connection with an existing development, supply and marketing agreement with Impax Laboratories (IPXL). The agreement designates IGI Laboratories as the developer, manufacturer, and owner of a generic topical pharmaceutical drug product, which will be licensed, marketed and distributed in the United States by Global Pharmaceuticals, Impax's generics division. In accordance with the agreement, Impax is required to pay IGI when certain milestones are met related to the filing and approval of the associated ANDA.
News For IG;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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