Medpharm: FDA approves Plan B, who owns it?

Manufacturing News, Source : The Manufacturer US
Published : 25 Aug 2006 15:10

Love it, hate it or debate it, the The Food and Drug Administration (FDA) has approved nonprescription sales of the "morning-after pill," called Plan B, to adults over 18. The Wall Street Journal expects this to significantly raise the profile of Barr Pharmaceuticals.

Who is Barr?

It is a publicly-held Delaware holding company whose principal subsidiaries, Barr Laboratories and Duramed Pharmaceuticals develop, manufacture and market generic and proprietary pharmaceuticals, respectively. The Company’s generic products are marketed under the “Barr” label, and proprietary products are marketed under the “Duramed” label.

The Duramed portfolio consists of 19 drugs, most aimed at women's health. This includes five oral contraceptives, including Plan B, and ENJUVIA, a once-daily oral estrogen therapy for treatment of vasomotor symptoms associated with menopause.

Specifically, FDA granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for women 17 and younger. The company had aimed for approval for women 16 years and older while maintaining the prescription status for women age 15 and younger.

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