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June 26, 2014
08:42 EDTMNK, IGMallinckrodt 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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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."
June 29, 2015
16:57 EDTMNKHikma, Mallinckrodt among bidders for Roxane Labs, Bloomberg says
Hikma (HKMPY) and Mallinckrodt (MNK) are bidding for Boehringer's Roxane Labs business, reports Bloomberg, citing people with knowledge of the matter. Roxane Labs could end up being purchased for over $2.2B, Bloomberg adds. Reference Link
15:01 EDTMNKMallinckrodt, Perrigo among bidders for Roxane Labs, Bloomberg reports
Mallinckrodt (MNK), Perrigo (PRGO) and Hikma are among the potential bidders for Boehringer Ingelheim's Roxane Labs generic business, said Bloomberg, citing people with knowledge of the matter.
June 23, 2015
11:12 EDTMNKMallinckrodt management to meet with Guggenheim
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