IGI Laboratories, Inc. a generic topical pharmaceutical company, has received its first approval from the US Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The FDA has approved IGI's application for lidocaine hydrochloride USP 4% topical solution.
Lidocaine hydrochloride USP 4% topical solution is indicated for the production of topical anaesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Based on recent IMS Health data, the total addressable market for this product is approximately $1.8 million. IGI originally submitted this ANDA to the FDA in May, 2012.
Jason Grenfell-Gardner, president and CEO of the company, commented, "Today's action by the FDA marks a true turning point in the transformation of IGI. With our first drug approval, organically generated from beginning to end within IGI, we have validated our team's ability to deliver on R&D. Although this particular drug is the smallest opportunity in our pipeline, it is an important milestone for demonstrating IGI's capabilities. With now 13 further applications pending, and at least nine more filings planned this year, IGI will continue to execute its R&D plan as part of our goal of being a leading player in the generic topical pharmaceutical market."