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news.IGI Laboratories, a US-based generic topical pharmaceutical firm, has submitted its seventh abbreviated new drug application (ANDA) in 2014 to the US Food and Drug Administration (FDA).
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The seventh ANDA filing was in connection with a current development, supply and marketing agreement with Impax Laboratories.
The deal designates IGI Laboratories as the developer, manufacturer and owner of a generic topical pharmaceutical drug product, which will be licensed, marketed and distributed in the US by Impax’s generics division Global Pharmaceuticals.
As part of the deal, Impax is required to pay IGI when certain milestones are met related to the filing and approval of the related ANDA.
IGI Laboratories president and CEO Jason Grenfell-Gardner said the company has collaborated with Impax over the past few years, and is grateful for the continued support from one of the leaders in the specialty pharmaceutical industry.
"We believe the addressable market for this product to be over $100 million based on recent data from IMS Health," Grenfell-Gardner said.
"We look forward to working with Impax to continue to help us grow our pipeline of generic topical prescription drugs."
IGI Laboratories develops and manufactures topical formulations for the pharmaceutical, over the counter (OTC) and cosmetic markets.