Ranbaxy Laboratories withdraws applications of 27 drugs filed with USFDA

NEW DELHI: India's Ranbaxy Laboratories has agreed to withdraw applications of 27 drugs filed with the US Foods and Drug Administration as part of a deal to resolve long-pending regulatory issues over its two plants in India.

"The drug products are no longer marketed, and Ranbaxy has requested that the approval of the applications be withdrawn," the FDA said. "The company has also waived its opportunity for a hearing."

The drugmaker's request follows a consent decree it signed with US authorities in January under which the drug company agreed to take a series of corrective measures and withdraw drug applications, which may contain fraudulent data. Most of these drugs are antibiotics. The biggest drug Ranbaxy is foregoing is anti-cholesterol drug pravastatin. "The decree specifies that Ranbaxy must never submit another application to FDA for these withdrawn drug products and must never transfer these Abbreviated New Drug Application (ANDAs) to a third party," FDA said.

Analysts said Ranbaxy's move was aimed at resuming supply of drugs made at its plants in Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh to the US, the world's largest drug market.

"The move is a step forward in terms of resolution of the FDA issue for its two banned manufacturing plants," said Hitesh Mahida, research analyst at Mumbai-based Fortune Equity Brokers. Majority of these products would not have had a major financial impact since there are many generic players, he said.

In September 2008, the FDA had banned 30 drugs made at these two plants for violating US drug manufacturing norms.

About a dozen of the applications Ranbaxy agreed to withdraw on Wednesday figure among these 30 drugs. A Mumbai-based analyst said Ranbaxy has a total of about 120 ANDA applications with the FDA.

Ranbaxy said the forfeiture would have minimal impact on its revenues.