IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has acquired the regulatory rights and related documents and records for 18 drug products from AstraZeneca, 17 of which were marketed. The acquisition includes the regulatory rights and documents for 17 injectable products and 1 suppository product. All of these products had been previously approved by the US FDA as abbreviated new drug applications (ANDAs) or new drug applications (NDAs) prior to their discontinuation or withdrawal from the market. According to IMS Health, the current addressable market in the United States for the therapeutic areas that these products were previously indicated for is estimated at $200 million as of May 2014.
Jason Grenfell-Gardner, President and CEO of IGI Laboratories, commented, "This acquisition begins the next critical phase of our growth strategy, and will enable us to expand our existing generic topical pharmaceutical platform to now include injectable products. Expanding our development and commercial focus to include injectable pharmaceutical products will leverage our existing expertise and capabilities, and broaden our platform for sustainable growth. Almost half of the products we acquired are currently listed on the US FDA shortage list, and we look forward to working closely with the US FDA to return these products to the market as soon as possible."
IGI Laboratories, Inc.