AstraZeneca Sells Off 17 Retired Injectables To IGI Labs

Specialty generic drug maker IGI Laboratories announced that it has acquired the regulatory rights to 18 formerly marketed products from British drug firm AstraZeneca.

The deal involves 17 injectables and 1 suppository product and includes related documents and records for the products. All have previously received approval from the U.S. Food and Drug Administration (FDA) as abbreviated new drug applications (ANDAs) or new drug applications (NDAs) before they were pulled out of the market.

Jason Grenfell-Gardner, President and CEO of IGI Laboratories, said, “This acquisition begins the next critical phase of our growth strategy, and will enable us to expand our existing generic topical pharmaceutical platform to now include injectable products. Expanding our development and commercial focus to include injectable pharmaceutical products will leverage our existing expertise and capabilities and broaden our platform for sustainable growth.” IGI Labs said that the U.S. market for the therapeutic areas for the products is estimated at $200 million this year according to the IMS Health.

Grenfell-Gardner added that nearly half of the products the company acquired from AstraZeneca are listed on the latest FDA shortage list. He said that the company anticipates working with the FDA to resolve the shortages for the products soon.

There are more than 120 products on the FDA’s current shortage list, two-thirds of which remain unresolved. The FDA takes a preventive strategy approach as opposed to focusing on resolving new shortages that arise. The agency emphasizes early notification to help prepare for the impending shortage by working with other manufacturers. The FDA also works on promoting good manufacturing quality, as problems in this area often contribute to shortages.

Injectables have been in demand in the market as of late. A similar deal centered on injectable drugs between Hikma Pharmaceuticals and Boehringer Ingelheim took place earlier this year. The London-listed Hikma acquired U.S. assets, which include cancer treatments and anti-infective vaccines, from the German drug maker for $300 million.