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Watson gains FDA approval for morning after pill Posted 03/08/2012

US generics company Watson Pharmaceuticals (Watson) announced on 13 July 2012 that its subsidiary Watson Laboratories, has received approval from FDA for its Abbreviated New Drug Application (ANDA) for Next Choice One Dose (levonorgestrel tablet, 1.5 mg), the generic equivalent to Teva Women’s Health’s Plan B One-Step. Watson plans to launch the product immediately.

Plan B One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. The drug alters the cervical mucus, exerts a progestational effect on the endometrium, interfering with implantation, and, for some, suppresses ovulation. It is available in the US without prescription for women over 16 years of age.

FDA approval of the ANDA for Next Choice One Dose makes the Watson product the only generic one-dose emergency contraceptive on the market. Watson is planning an immediate launch of the generic contraceptive tablet.

For the twelve months ending 31 May 2012, Teva’s Plan B One-Step had total US sales of approximately US$88 million according to IMS Health data.

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Source: Watson

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