FDA Rescinds Tentative Approval for Ranbaxy’s Generic Nexium

Nov. 6 (Bloomberg) — The U.S. Food and Drug Administration withdrew its tentative approval of Ranbaxy Laboratories Inc.’s generic version of the acid-reflux medication Nexium.

The FDA also reversed its preliminary approval of another Ranbaxy generic, a copy of Roche Holding AG’s anti-viral drug Valcyte, citing the “compliance status” of the facilities that Ranbaxy would use to manufacture the drugs, the Indian drugmaker said in a statement today.

“Ranbaxy is disappointed with this development,” the Gurgaon, India-based company said.

The decision is good news for AstraZeneca Plc, which has been bracing for generic competition to Nexium after the drug lost patent protection in the U.S. in May. For Sun Pharmaceutical Industries Ltd., which agreed in April to buy Ranbaxy, the loss of the generic Nexium approval adds to the challenge of bringing into compliance four Ranbaxy facilities banned from making drugs for the U.S.

AstraZeneca earned $3.9 billion last year from sales of Nexium, its second-best selling drug. Roche’s antiviral treatment Valcyte had sales of $748 million last year.

To contact the reporter on this story: Ketaki Gokhale in Mumbai at [e-mail] To contact the editors responsible for this story: Anjali Cordeiro at [e-mail] Marthe Fourcade, John Bowker