The Food and Drug Administration’s Drug Competition Action Plan begins with a public hearing on July 18 to assess the places where FDA regulations could be creating obstacles to generic access.
Camber’s generic will be available in 20-, 40-, and 80-mg dosage strengths and packaged in 3x10 blister cards.
According to the CDC, American adults are behind on routine annual vaccinations.
The company said that it’s expecting a launch in the second-half of 2017, and that it has already submitted an application to the FDA for a junior version of Symjepi.
The drug is indicated as an adjunctive therapy to relieve discomfort associated with acute, painful musculoskeletal conditions.
This launch marks the seventh product ANI has re-commercialized after acquiring a portfolio of discontinued generic abbreviated new drug applications.
The company said that this marks its fourth first-to-market generic launch since June 2016.
The drug had U.S. sales of $15 million for the 12 months ended April 2017, Perrigo said.