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US FDA approves acne medication Absorica

28 May 2012 | Regulatory | By BioSpectrum Bureau

US FDA approves acne medication Absorica

Ranbaxy will launch the product in the US in fourth quarter of 2012

Ranbaxy will launch the product in the US in fourth quarter of 2012

New Delhi: The US Food and Drug Administration (FDA) has approved Absorica, a novel, patented brand formulation of the acne medication isotretinoin, developed by Cipher, for the treatment of severe recalcitrant nodular acne. Ranbaxy Laboratories, which has an agreement with the Canadian firm Cipher Pharmaceuticals, is expected to launch Absorica in the US in Q4 2012. As per the agreement, Ranbaxy will pay royalties on net sales of Absorica to Cipher.

"We are thrilled to make Absorica available as a valuable option for the dermatologists and patients who need treatment for severe recalcitrant nodular acne. Absorica is a critical milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy's specialized dermatology sales force," said Mr Venkat Krishnan, senior vice president and regional director, Americas, Ranbaxy.

"Approval of Absorica represents our third FDA approval and most important milestone to date, reflecting the great work by our scientific affairs team at Cipher and our partner, Galephar Pharmaceutical Research," said Mr Larry Andrews, president and CEO of Cipher. "We look forward to working closely with our partner, Ranbaxy, in preparation for the upcoming US launch of the product through its dermatology sales force."

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