Ranbaxy sues US drug regulator over revoking approvals

Daiichi Sankyo-controlled Ranbaxy Laboratories has sued the US Food & Drug Administration (FDA) for revoking approvals granted to it to launch copies of two drugs—AstraZeneca’s Nexium and Roche AG's Valcyte.

Reuters, which first reportedthe development citing court documents, added that Ranbaxy has filed a suit in the District Court for the District of Columbia and has argued: “The FDA's move violated constitutional rights, exceeded the agency's statutory authority, and was "arbitrary, capricious, and otherwise contrary to law. The FDA has no power to correct an alleged mistake it made six years ago."

In an emailed statement to VCCircle, Ranbaxy spokesperson said: “Following, and in response to, the revocation of Ranbaxy’s tentative approvals for Ranbaxy’s ANDAs for esomeprazole magnesium delayed-release capsules and valganciclovir hydrochloride tablets, Ranbaxy has filed a complaint against the USFDA in D.C. federal court and has also asked the Court for a temporary restraining order to prevent any further action by FDA until Ranbaxy’s case is decided.”

Early this month the American drug regulator revoked Ranbaxy’s tentative approval for selling copycat low-cost versions of blockbuster heartburn drug Nexium and antiviral drug Valcyte in the world's largest drug market.

The FDA said it had made an error in granting approval given the compliance status of the plants which were to produce the generic versions of the blockbuster drugs.

The FDA later allowed Dr Reddy's along with US-based Endo for one of the above mention drugs Valcyte. Valcyte is an antiviral medicine made by Roche.

The move takes out a big revenue earning potential for the Indian drugmaker, which was also seen as a critical part of the proposed deal with Sun Pharma.

Sun Pharma had announced plans to acquire Daiichi Sankyo-controlled Ranbaxy in an all stock deal worth $4 billion, including debt.

Ranbaxy held an approval for the two drugs even though all its four manufacturing units in India are currently barred from making products for sale in the US.

The delay in launching low cost versions of the medicines was also affecting US consumers as they were forced to buy the original innovator drug at a higher price.

Ranbaxy has been under the scanner of FDA over various issues which had led the US drug regulator to ban import of products made at all its Indian plants.

(Edited by Joby Puthuparampil Johnson)

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