The Food and Drug Administration has shared a list of drugs without patents or exclusivity that don't yet have generics, and has outlined a new plan for expediting review of generics of drugs with limited competition.
The drug is indicated to treat schizophrenia and to control severe nausea and vomiting in adults.
Born in Rajgarh, Rajasthan, Gupta moved to Mumbai and founded Lupin in 1968 with the goal of providing high-quality medicines at affordable prices.
Teva’s generic will be available in 75- and 150-mg dosage strengths.
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.