New Delhi, Dec. 26: Domestic pharma major Ranbaxy Laboratories Ltd (RLL) today announced that US authorities have given it the nod to enter the $ 523-million market for recalcitrant acne by making and marketing Isotretinoin.
Isotretinoin capsules are indicated for severe recalcitrant nodular acne. Overall sales of Accutane in the US totalled $ 523 million according to data available in September 2002. Isotretinoin is therapeutically equivalent to Accutane, the patent for which is with global pharma major Roche.
Ranbaxy is also engaged in the launch of generic Co-Amoxyclav in USA, scheduled to be out by January, CEO and managing director D. S. Brar said, adding that Isotretinoin represents a significant milestone for the company. Ranbaxy said based on pharmacokinetic studies, its formulation has been deemed to be therapeutically equivalent to Accutane capsules in 10mg, 20mg and 40mg respectively, the dosages for which Ranbaxy has received approval from the US Food and Drug Regulating Authority (USFDA).
The company added that the USFDA approval to manufacture and market Isotretinoion came two days back. The production of the drug will be carried out in one of Ranbaxy’s facilities in India and the final product to be sold in US will be marketed and distributed by the wholly-owned US subsidiary of Ranbaxy, a company spokesperson said.
Ranbaxy has been engaged preparing to launch Isotretinoin in the US for quite some time, including patient monitoring and patient education programmes. The final launch plans are being firmed up, a company spokesperson said.