Generic Plan B approved by FDA

Posted by: admin  :  Category: Pharmacy news

Jul 14, 2009
By: Alaina Scott, Senior Editor
Drug Topics E-News

The Food and Drug Administration has approved the first generic version of the 0.75 mg Plan B emergency contraceptive tablets. For women ages 17 and under, levonorgestrel, the generic product, will be available by prescription only.Plan B, manufactured by Duramed Pharmaceuticals of Cincinnati, was first approved in 1999 for prescription use only by women of all ages. In 2006, Plan B was approved for nonprescription use by women ages 18 and older, remaining available by prescription only to women ages 17 and under.

The latest approval permits marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use by women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity for nonprescription use held by Duramed expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories in Corona, Calif.

Levonorgestrel can prevent pregnancy after unprotected intercourse and after 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.

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