Watson Pharmaceuticals says that regulators in the USA have given the green light to the company’s generic version of Teva Pharmaceutical Industries’ Plan B One-Step emergency contraceptive.
Watson’s version of Plan B One-Step (levonorgestrel) has been approved by the US Food and Drug Administration approval. The treatment will be called Next Choice One Dose and the company intends to launch it immediately.
US sales of Plan B One-Step were $88 million for the year ending May 31. It is used to prevent pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
FTC wants more info on Actavis purchase
Meantime, Watson has recently received a request for additional information from the Federal Trade Commission in connection with its pending acquisition of fellow generics major Actavis.
The effect of this ‘second request’ is to extend the waiting period until 30 days after Watson and Actavis have “substantially complied” with the request, as the FTC looks at possible antitrust issues.
Watson, which is paying an initial 4.25 billion euros for Actavis, says it intends to cooperate fully with the FTC’s review and continues to expect the transaction to close in the fourth quarter of 2012.
