Ranbaxy Laboratories' entry into the global anti-acne market is likely to be delayed as the mandatory inspection by the US Food and Drug Administration (US FDA) for the company's ANDA (Abbreviated New Drug Application) for the generic isotretinoin has been postponed. The US FDAs investigator had not yet arrived.
The US FDA has already approved its manufacturing facility for the product. A special investigator for checking the manufacturing process has, however, not arrived as per schedule. Ranbaxy had applied for Para III filing to get the nod for marketing the generic isotretinoin.
Pharma major Roche Laboratories holds the patent for the active ingredient and markets it under the brand, Accutane. Accutane is used in the treatment of severe recalcitrant nodular acne. One other large US generic company, Mylan, is also expected to be in the race to manufacture and market the drug. The patent for isotretinoin will expire in February 2002. The worldwide sales of Accutane are about $757 million and are growing at about 8% - 10% .
The US FDA has been quite stringent in its inspections for the anti-acne drug to check for possible side effects. The drug is suspected to have side effects, particularly depression. Hence, the US FDA is expected to be quite rigid in granting approvals for this generic drug.