The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.
In its first year, more than 20,000 schools across all 50 states participated in the program that offers four free EpiPen or EpiPen Jr (epinephrine) Auto-Injectors to qualifying schools in the United States.
Mike Aigner, director of national accounts, Mylan
Q: What do you hope to get out of the RBC show?
A: We'd like to reach as many customers as possible. Cardinal has been an absolutely great partner for many years.
A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.
While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.