FDA Drops Access Restrictions On Generic OTC Emergency Contraceptives

05 Mar 2014

• By Emily Hayes

In a recent letter to drug firms, FDA rejects Plan B One-Step manufacturer Teva’s requests to restrict sales and labeling of generic equivalents. Labeling for the generics will not prevent consumers under 17 from buying the products nor require retailers to ask consumers for proof of age.

FDA will allow OTC sales of private-label versions of Teva Pharmaceutical Industries Ltd.’s emergency contraceptive Plan B One-Step without label restrictions that Teva proposed for the generic equivalents.

The agency’s Center for Drug Evaluation and Research says it will accept labeling for private label versions of Plan B...