Boston, MA, 03/13/2014 – IGI Laboratories Inc (NYSEMKT:IG) announced that the U.S. Food and Drug Administration has approved of its new drug, abbreviated as ANDA.
The FDA has approved IGI Lab’s application for lidocaine hydrochlioride USP 4% topical solution. This is the first FDA approval for the New Jersey based generic topical pharmaceutical company. It had first submitted ANDA for approval with the FDA in May, 2012. The solution is targeted to produce topical anesthesia of accessible mucous membranes of the nasal and oral cavities and proximal parts of the digestive track.
IGI Laboratories Inc (NYSEMKT:IG)’s President and Chief Executive Officer, Jason Grenfell-Gardner believes the FDA approval to be a turning point in the transformation of the company. He said that the approval of the company’s drug which has been organically generated entirely within the company shows the efficiency of the team’s potential to deliver on research and development. He also said that this drug is the smallest opportunity in the company’s pipeline, but is nevertheless an important milestone for them.
9 ANDAs in 2014
According to the recently collected IMS Health data, the total addressable market for lidocaine hydrochlioride USP 4% topical solution is close to $1.8 million. Apart from this, IGI Labs has several more ANDAs on file with the FDA. Generally, it takes around 3 years for getting the approval. With 14 ANDAs waiting for approval, the management targets a combined addressable market of around $330 million. This value is again based on the recent data from IMS Health. IGI Labs plans to file as many as 10 ANDAs this year. Analysts believe that these efforts could lead the company to stable long term sources of revenue.
A small cap developer, producer and marketer of generic topical pharmaceutical products, IGI Laboratories Inc (NYSEMKT:IG) mostly avoids costly clinical studies using the ANDA process. By focusing on generic formulations, it typically does not demand characteristic NDA approval for new drugs.