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News Breaks
June 26, 2014
08:42 EDTIG, MNKMallinckrodt grants IGI Labs non-exclusive license to launch generic PENNSAID
IGI Laboratories (IG) announced that it has entered into an agreement with Mallinckrodt (MNK) and Nuvo Research to settle a declaratory judgment action brought by IGI, concerning IGI's filing of an abbreviated new drug application with the FDA seeking approval to market a generic version of PENNSAID 1.5% w/w. Under the terms of this agreement, Mallinckrodt granted IGI a non-exclusive license to launch its diclofenac sodium topical solution 1.5% product on March 28, 2015. IGI received tentative approval of its diclofenac sodium topical solution 1.5% from the FDA on May 7. IGI CEO Jason Grenfell-Gardner said, "The agreement provides IGI with a date certain launch of diclofenac sodium topical solution 1.5%. We remain confident in our ability to obtain final FDA approval of our ANDA for diclofenac sodium topical solution 1.5% prior to our agreed upon launch date. The agreement allows IGI to continue to expand its portfolio of generic topical prescription drug products."
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16:02 EDTIGIGI Laboratories files to sell $125M of convertible senior notes due 2019
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