August 14, 2009 / 9:32 PM / 10 years ago

UPDATE 1-Hospira says FDA suspends oxaliplatin approval

* Says FDA suspends generic temporarily due to law case

* Says suspension not related to drug safety, efficacy

By Ransdell Pierson

NEW YORK, Aug 14 (Reuters) - Hospira Inc HSP.N on Friday said U.S. regulators had suspended its approval, received only three days earlier, to sell a generic injectable formulation of Sanofi-Aventis’ (SASY.PA) colon cancer drug Eloxatin.

“The suspension is related to legal proceedings initiated by the innovator company (Sanofi) against the Food and Drug Administration and a court order issued in that proceeding,” Hospira said in a filing registered with the Securities and Exchange Commission.

Hospira said the FDA informed it the suspension is temporary, until the court has had a chance to consider arguments to be filed on Aug. 18.

“The suspension is not related to the safety and efficacy of the product,” Hospira said, noting it has temporarily halted shipments of its generic.

Hospira on Tuesday said it had launched the generic, after winning FDA approval for the product. The generic medicine is known by its chemical name, oxaliplatin.

The branded Sanofi product garnered U.S. sales last year of about $1.4 billion, Hospira said, and is used to treat advanced colon cancer and for some patients who have undergone surgery to remove colon tumors.

Hospira, in the same filing, said it received a warning letter from the FDA on Thursday, related to the company’s corrective action plans following failure of power cords made by a third party.

The company said the electrical cords are used on some of its infusion pumps and related equipment, and that it will respond fully and in a timely manner to the FDA’s warning letter.

Hospira officials could not comment beyond its regulatory filing.

The company’s specialty injectable pharmaceuticals business offers about 200 generic injectable drugs in various doses and formulations.

Hospira shares were unchanged in after-hours trading from their closing price of $40.09 on the New York Stock Exchange. (Reporting by Ransdell Pierson; Editing by Gary Hill)

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