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Watson Pharmaceuticals Receives FDA Approval For Generic PLAN B For Over-the-Counter Use

PBR Staff Writer Published 28 August 2009

Approved for over-the-counter use in women ages 17 and above, and for prescription use in women under the age of 17

Watson Pharmaceuticals has announced that its subsidiary, Watson Laboratories has received approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75mg. Levonorgestrel is approved for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17.

Levonorgestrel tablets, 0.75mg is the generic equivalent to Duramed Pharmaceuticals' PLAN B (Rx/OTC), which is indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure. Watson will market the product under the trade name Next Choice and plans to launch the product shortly.

On June 24, 2009, Watson received FDA approval of Next Choice (levonorgestrel) Tablets, 0.75mg for prescription use. Following this approval, Next Choice is now labeled for both prescription and over-the-counter use.