FDA GRANTS OTC STATUS TO PLAN B® EMERGENCY CONTRACEPTIVE

Story Summary:

FDA Grants OTC Status to Plan B® Emergency Contraceptive
The U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) filed by Barr Pharmaceuticals, Inc.’s wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., to market the Plan B® (levonorgestrel) emergency contraceptive Over-The-Counter (OTC) without a prescription for consumers 18 years of age and older, while maintaining the prescription status for women17 and younger. The Company’s Plan B OTC product and the prescription product will be in the same package, which will allow for a prescription label to be adhered to the package dispensed to women age 17 and younger.

Plan B will be sold from behind the pharmacy counter. Duramed plans to introduce the dual status Rx/OTC version of the product before the end of the calendar year.

Soundbites

• Nancy Roberson Jasper, MD, Assistant Clinical Professor of Obstetrics and Gynecology at the College of Physicians and Surgeons at Columbia University
• Kathleen Hill-Besinque, Pharm.D., Associate Professor of Clinical Pharmacy at USC School of Pharmacy

B-Roll Includes

• Plan B Packaging
• Barr Pharmaceuticals’ Manufacturing and Laboratory Footage
• Pharmacy Dispensing
• Soundbites

VIDEO PROVIDED BY: "Barr Pharmaceuticals, Inc., Carol Cox, VP Investor Relations and Corporate Communications, 400 Chestnut Ridge Road,
Woodcliff Lake, NJ, 07677: 201-930-3720"