FDA to Revoke NDAs for 13 Products Over Failure to Submit Annual Reports

The FDA has withdrawn approval of 13 NDAs, including for drugs to treat pain and hypothyroidism, after the manufacturers repeatedly failed to submit mandatory annual reports on the products.

The companies did not respond to the agency’s November 2013 request to attend a hearing on proposals to revoke the approvals, according to an FDA notice in the Federal Register. As a result, they waived their opportunity to raise any contentions over the legal status of the products.

The products include four containing the hormone corticotropin and six containing cyanocobalamin and other B vitamins. The others contain methandriol, seractide acetate and protirelin.

The notice did not say the withdrawal was related to safety or efficacy reasons.

View the list of drugs and applicants here: www.fdanews.com/11-14-FDA-Notice.pdf. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.