FDA approves Teva’s one-pill emergency contraceptive
Teva Pharmaceuticals last month gained Food and Drug Administration approval for its Plan B One-Step, a line extension of the emergency contraceptive that changes the two-pill regimen associated with Plan B to just one pill.
OTC availability for women age 17 years old is new as well—a federal judge ordered the FDA to lower the OTC age limit for Plan B from 18 years to 17 years in April, though the agency noted it would need a new drug application from Teva in order to accomplish that. Plan B One-Step will begin shipping by August, Teva reported.
“I prefer one-pill dosing for my patients because it allows them to act more quickly, while providing a high level of safety and efficacy,” said Ashlesha Patel, division director of Family Planning Services at John H. Stroger Jr., Hospital. “Emergency contraception is more effective the sooner it’s taken, and Plan B One-Step provides a back-up plan that’s just one pill away.”
Awareness of Plan B has increased significantly since OTC approval in 2006, Teva reported. More than 88% of 18- to 30-year-olds categorize Plan B as emergency contraception, up from 64% in 2006. And 86% of individuals understand that the product prevents, rather than terminates, pregnancy, unlike the prescription “abortion pill” RU-486.
Additionally, U.S. retail pharmacists are overwhelmingly compliant with dispensing guidelines. Within one year post-OTC approval, 99% of pharmacists who sold Plan B were aware of its dual-label status—it’s prescription-only for women younger than 17—and 95% were comfortable selling/dispensing Plan B.
Teva’s original Plan B formulation was opened to generic competition last month, as Watson Labs obtained approval for its Next Choice levonorgestrel brand, though only as a prescription for women younger than 17. Teva has patent protection on the OTC indication through Aug. 24.
For the 12 months ended March 2009, Plan B had total U.S. sales of approximately $123 million, of which approximately 10% are attributable to prescription sales, Watson reported, citing IMS sales data.