Ranbaxy sues US drug regulator for revoking approvals

NEW DELHI: Drug maker Ranbaxy Laboratories, which is yet to resolve its long pending issues with the US drug regulator, has sued US Food and Drug Administration (US FDA) for revoking approvals granted to the firm for launching low-cost versions of two bestselling medicines -- Nexium and Valcyte -- used in treatment of heartburn and for infection caused by HIV, respectively.
Earlier this month, the US FDA withdrew its decision to grant tentative approvals to Ranbaxy for the two generic drugs citing the compliance status of Ranbaxy production facilities.The regulator had said its original decisions were in error because it found Ranbaxy’s plants at the time were not compliant with the regulatory norms.
In its latest suit filed in the US district court of Columbia, Ranbaxy alleged US FDA's move violated “constitutional rights” and was “arbitrary, capricious, and otherwise contrary to law”.
“FDA has no power to correct an alleged mistake it made six years ago,” Ranbaxy said in the court filing, reviewed by TOI.
In the lawsuit, Ranbaxy also requested the court to restrain FDA from approving any other generic versions of Valcyte or Nexium until its six-month exclusive periods on the launch of the drugs has ended.
However, after withdrawing tentative approvals granted to Ranbaxy's drugs, the US FDA granted final approval to another Indian generic drug maker Dr Reddy’s Laboratories and the US-based Endo International Plc to launch copies of Valcyte.
Some analysts had expected Nexium to fetch Ranbaxy as much as $180 million in sales in the US in six months, while Valcyte was expected to bring in $40-50 million.
Ranbaxy, which is in the process of being acquired by rival drug maker Sun Pharma, was the first company to receive tentative approvals to launch generic versions of the two drugs, making it eligible to exclusively market the medicines for six months -- a huge revenue generating opportunity.
Ranbaxy has been facing troubles in the US for the past many years as all its manufacturing facilities in India are barred from supplying to the American market.