FDA extends approval time for COPD drug by three months


NEW YORK — Regulators will take a few months longer to review the approval application for a new drug for treating chronic obstructive pulmonary disease, the drug's developers said Thursday.

Forest Labs and Almirall said the Food and Drug Administration would require a three-month extension to complete its review of their application for aclidinium bromide, a maintenance drug for COPD. The FDA plans to complete its review and decide whether or not to approve the drug in July.

In February, the FDA's Pulmonary-Allergy Drugs Advisory Committee voted 12-2 in favor of recommending the drug's approval. Advisory committee votes don't guarantee approval for a drug, but FDA decisions usually are consistent with them.

Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter.

This ad will auto-close in 10 seconds