US FDA removes Ranbaxy's 27 ANDAs under consent decree

Moneycontrol Bureau

The US Food and Drugs Administration is removing 27 Abbreviated New Drug Application (ANDA) approvals held by generic drugs maker Ranbaxy Laboratories.

"The FDA is withdrawing approval of 27 ANDAs held by Ranbaxy...The drugs are no longer marketed...Ranbaxy requested withdrawl of approval under a consent decree of permanent injunction entered on January 26, 2012," it said in a letter posted on The Office of the Federal Register website.

Ranbaxy had entered into a consent decree with US FDA to resolve its long pending issues related to the drug regulator blacklisting its plants in Dewas and Paonta Sahib.

In 2008, the US FDA had banned Ranbaxy from exporting 30 drugs from its facilities in Dewas, Madhya Pradesh and Paonta Sahib, Himachal Pradesh and also stopped marketing approvals for new ones following quality control and data reporting issues.

In the consent decree, Ranbaxy said it has committed to further strengthen procedures and policies to ensure data integrity and comply with current good manufacturing practices.

"The decree specifies that Ranbaxy must never submit another application to FDA for these withdrawn drug products and must never transfer these ANDAs to a third party.," FDA said.

The Ranbaxy's 27 ANDA approvals withdrawn include antibiotics Cefaclor capsules and suspension, Cefadroxil, Dispermox (amoxicillin tablets for oral suspension), Fluconazole (treatment of fungal infections) and Glimepiride tablets (diabetes treatment) in 1mg, 2mg, 4mg and 8mg among others.

In a separate notification to the stock exchanges, Ranbaxy said that the ANDAs don't pertain to current business and will have a negligible impact on its business in the US market.

"The company has determined that certain products with negligible commercial impact should be withdrawn to enable the organisation to focus resources on other applications that are of greater importance and value to the US business and healthcare system," it said.

Ranbaxy shares were trading at Rs 523.35, up 1.8% on NSE in noon trade on Wednesday.