US Bioservices has been around for more than 20 years, offering support and dispensing services for patients who need specialty medications.
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 Preserving Patient Access to Compounded Medications Act of 2017 would clarify the Drug Quality and Security Act in a way that would align the statute with congressional intent to balance the issues of public safety and patient access.
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.