Mayne Pharma gets FDA nod for first Acticlate generic

SILVER SPRING, Md. — The Food and Drug Administration has approved Mayne Pharma’s generic of Acticlate (doxycycline hyclate) immediate release tablets, the company announced recently. Mayne Pharma’s will be the first generic of the treatment for infections, including severe acne.

“We are very pleased to have launched the first generic alternative to Acticlate in the US, providing more choices to patients and payers in terms of medication affordability,” Mayne Pharma CEO Scott Richards said. “Today’s approval exemplifies Mayne Pharma’s commitment to bringing first-to-market generic products to the marketplace.”

The company said that this marks its fourth first-to-market generic launch since June 2016. The Acticlate generic will be available in 75- and 150-mg dosage strengths. The drug had U.S. sales of $250 million for the 12 months ended April 2017, according to QuintilesIMS data.