FDA Rescinds Tentative Approval For Ranbaxy’s Generic Nexium

The Food and Drug Administration withdrew its tentative approval of Ranbaxy Laboratories Inc.’s generic version of the heartburn tablet Nexium and one other copycat medicine, a setback related to manufacturing conditions at its Indian plants.

The FDA blamed the “compliance status” of Ranbaxy’s manufacturing facilities to justify its decision, the Indian drugmaker said in a statement Nov. 6. The U.S. regulator also reversed its preliminary approval of Ranbaxy’s copy of the Roche Holding AG anti-viral Valcyte.

The decision is a boon for AstraZeneca Plc, which has been bracing for competition to Nexium after the drug lost patent protection in the ...