Frovatriptan succinate tablets, the generic equivalent to Frova tablets, is administered for acute migraine headache treatment in adults.
Mylan has launched frovatriptan succinate tablets, 2.5 mg, which are the generic equivalent to Endo’s Frova tablets.
The FDA recently granted approval for Mylan’s abbreviated new drug application for the acute migraine headache treatment for adults.
The safety and efficiency of Frova was examined in 5 double-blind, placebo-controlled, outpatient trials. The trials showed that the drug could reduce the pain associated with moderate to severe headaches.
The most common adverese effects were nausea, vomiting, phonophobia, and photophobia.
Frova is not recommended for patients with ischemic heart disease or uncontrolled hypertension.
US sales for this drug reached approximately $88 million for the 12 months ending in March 31, 2016, according to IMS Health.
To date, Mylan has 260 abbreviated new drug applications pending FDA approval.