FDA grants exclusivity to Teva Plan B One-Step
This article was originally published in Scrip
Executive Summary
The US FDA has granted Teva exclusivity protection ensuring the company's Plan B One-Step (1.5 mg levonorgestrel tablet) is the only single-pill emergency contraceptive permitted to be sold over-the-counter (OTC) without a prescription to women and girls of all ages – shutting generics out of that US market for the next three years.