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

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

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

Genéricos/Novedades | Posted 16/10/2009 0 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.

References:
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