IGI Labs. Announces Joint Stipulation

BUENA, N.J., June 26, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced that it has entered into an agreement with Mallinckrodt LLC, Mallinckrodt Inc., and Nuvo Research, Inc. NRI (together Mallickrodt) to settle a declaratory judgment action brought by IGI, concerning IGI's filing of an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of PENNSAID (diclofenac sodium topical solution) 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, 2014. Jason Grenfell-Gardner, President and CEO of the Company, commented, "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."