IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted three additional abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to eleven, with twenty-two submissions now pending at the FDA.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "In February of 2014, we committed to file ten ANDAs in 2014. After today's ANDA submissions, we have submitted eleven applications to the FDA in 2014. I am extremely proud of the dedication and accountability of our team- we made commitments and we delivered. Our TICO strategy is focused on the topical, injectable, complex and ophthalmic prescription markets. The topical development engine is running smoothly, and we expect to average one to two topical ANDA submissions per month in 2015. We believe the three ANDAs filed today have a combined addressable market of $39 million based on October 2014 data from IMS Health. We believe our current pipeline of submissions, exclusive of partnered submissions, pending approval by the FDA now has a combined addressable market of over $551 million based on October 2014 data from IMS Health."