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News Breaks
June 20, 2014
08:03 EDTIPXL, IGIGI 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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June 30, 2015
16:13 EDTIGIGI Laboratories submits fifth ANDA submission for 2015
IGI Laboratories announced it has submitted its fifth abbreviated new drug application, ANDA, to the FDA of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-seven. Jason Grenfell-Gardner, President and CEO of the Company, commented, "We believe our current pipeline of twenty-seven submissions, exclusive of our four partnered submissions, pending approval by the FDA now has a combined addressable market of over $939 million based on May 2015 data from IMS Health. We still expect to submit a total of 20 ANDAs in 2015."

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