Barr gets FDA approval for new strength of acne drug

Barr, which markets its line of isotretinoin capsules under the tradename Claravis, will launch the new dosage strength immediately. The 30mg dose capsule will now join the 10mg, 20mg and 40mg capsules already on the market.

Claravis Capsules, 30mg will compete with Ranbaxy's own generic version of the product, Sotret Capsules 30mg, which had total annual sales of approximately $15 million for the most recent twelve months ending March 2006, according to data cited by the company.

Although the drug is a generic equivalent of the Roche product, Roche dose not market a 30mg strength.

The drug, indicated for the treatment of severe acne, is hampered by its potentially serious side effects. Patients on isotretinoin have been known to become depressed or to develop other serious mental health problems, whilst exposure to the drug during pregnancy can cause severe birth defects.

Patients should be aware of other serious side effects, including problems with the pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. The most common, less serious adverse events include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.