FDA Approves Generic Anti-Arrhythmic Drug

The FDA recently approved an Abbreviated New Drug Application (ANDA) for dofetilide capsules and have granted Mayne Pharma market exclusivity for 180 days.

The approved drug is a generic version of Tikosyn, which is an anti-arrhythmic drug used to treat irregular heartbeats, according to the Mayne Pharma press release.

Because Mayne Pharma was the first pharmaceutical company to file a completed ANDA, the FDA granted the company market exclusivity. According to the press release, they will begin selling the dofetilide capsules immediately.

The FDA also has recently withdrawn the Tikosyn Risk Evaluation and Mitigation Strategies program, which means that the availability of dofetilide capsules will not be limited.