FDA approves generic prescription-only version of Plan B emergency contraceptive levonorgestrel for women ages 17 and under

Generics/News | Posted 16/10/2009 post-comment0 Post your comment

The US FDA on 24 June 2009 approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.


Plan B was first approved in 1999 for prescription use only for women of all ages. Plan B is manufactured by Duramed Pharmaceuticals Inc of Cincinnati, USA, a subsidiary of Barr, which has been acquired by Teva.

In 2006, Plan B was approved for non-prescription use for women ages 18 and older. Plan B remained available as a prescription-only product for women ages 17 and under. Today's approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception could be approved for non-prescription use in women ages 18 and older until 24 August 2009, when the marketing exclusivity held by Duramed for the non-prescription use expired.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories Inc based in Corona, California, USA. Watson Pharmaceuticals Inc is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialised portfolio of brand pharmaceuticals focused on urology, women's health and nephrology/medical. The Company intends to market the product under the trade name Next Choice and plans to launch the product shortly. For the 12 months ending March 2009, Plan B had total US sales of approximately US$123 million (Euros 86.10 million), of which approximately 10% are attributable to prescription sales, according to IMS sales data.

Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection.

FDA news release 24 June 2009. FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under.

Business Courier 18 July 2008. Duramed parent Barr Pharmaceuticals to be acquired by Teva.

Medical News Today 4 July 2009. Watson Pharmaceuticals Receives FDA Approval For Generic PLAN B(R).

Source: FDA news; Business Courier; Medical News Today

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