BUENA, N.J., May 7, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced that it has received tentative approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for diclofenac sodium topical solution, 1.5%.
Diclofenac sodium topical solution, 1.5% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee. Based on recent IMS Health data, the total addressable market for this product is approximately $29 million. IGI originally submitted this ANDA to the FDA in December 2010.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "This tentative approval marks the second approval of an IGI ANDA by the FDA and we believe is a further validation of IGI's pipeline. The launch of this product will be conditioned on resolving the patent issues that surround the product. As a result of this approval, we now have 12 ANDAs pending at the FDA and we anticipate submitting at least a further nine ANDAs throughout the remainder of 2014."
About IGI Laboratories, Inc.
IGI Laboratories is a generic topical pharmaceutical company. We develop and manufacture topical formulations for the pharmaceutical, OTC, and cosmetic markets. Our mission is to be a leading player in the generic topical prescription drug market.
For further information:
Jenniffer Collins
IGI Laboratories, Inc.
(856) 697-4379
www.igilabs.com