May 7, 2014
/PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a
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
. IGI originally submitted this ANDA to the FDA in
, President and CEO of the Company, commented, "This tentative approval marks the second approval of an
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.
This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as "plan," "believe," "continue", "should" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions. These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in IGI Laboratories, Inc.'s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission. IGI Laboratories, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.