Product News and Recalls

Teva Pharmaceuticals Granted Exclusive Rights by FDA to Retail One-Step Plan B

According to a report from The Boston Globe, the US Food and Drug Administration (FDA) has granted Teva Pharmaceuticals the exclusive right to place its emergency contraception, One-Step Plan B, on the shelves of drugstores without any age restrictions. Exclusivity was granted for the next three years.

This was made possible when US District Judge Edward Korman of New York ordered in April, 2013 that all levonorgestrel-based emergency contraceptives be available over the counter without a prescription. Judge Korman’s order ended more than a decade of legal and regulatory quarreling over the controversial morning-after pill.

One-Step Plan B is manufactured by the Israel-based pharmaceutical firm Teva and retails for about $50 a dose. It contains the synthetic hormone levonogestreal, which blocks ovulation and impedes the mobility of sperm. Teva has recently been the focus of thousands of lawsuits over a different form of daily birth control marketed as Ocella and Gianvi. These brands contain drospirenone, which has been linked to an increased risk of blood clots.

One-Step Plan B is not a regular method of birth control. Its packaging indicates that it can be taken safely by females of all ages to prevent pregnancy within 72 hours of unprotected sex. These claims are supported by Teva Pharmaceutical’s clinical trial data which was submitted to the FDA for review in June, 2013.

A spokesperson from the FDA said the decision to grant Teva exclusive marketing rights was determined by the fact that Teva was the only one to provide the FDA with research data that supported the safe over-the-counter use of emergency contraception in teens under the age of 17.

The attorneys at Lopez McHugh will continue to monitor the developments related to the One-Step Plan B in addition to the traditional birth control methods. Please consult with your doctor before making any medical decisions.