Ranbaxy Launches New Dosage Strengths of Its Acne Drug Absorica

October 3, 2014

Ranbaxy’s U.S. brand distribution branch has launched two new dosage strengths of its acne drug Absorica.

Already available in 10 mg, 20 mg, 30 mg and 40 mg doses, the Indian generics maker said last week that Absorica (isotretinoin) will now also be available in 25 mg and 35 mg capsules in the U.S. Absorica’s active ingredient is dosed by patient weight, meaning the new strengths will give additional flexibility to doctors prescribing the drug for those living with severe recalcitrant nodular acne, Ranbaxy said.

Ranbaxy holds the U.S. NDA for Absorica, which it licenses from Cipher Pharmaceuticals.

A high risk of birth defects for expectant mothers on Absorica has led to a REMS program for the drug. In addition, some patients on or recently off the drug have developed depression or psychotic symptoms, although a direct link has not been established, Ranbaxy said. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.