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Pharmacy NewsFriday 3 July 2009
FDA Approves Watson's Generic Version Of Barr's Contraceptive Pill Seasonale; Both Companies To Launch Generic Versions
FDA on Thursday approved Watson Pharmaceuticals' marketing application for its generic version of Barr Laboratories' extended-cycle oral contraceptive Seasonale, Reuters reports. A Barr subsidiary also will launch a generic version, to be sold under the name Jolessa (Reuters, 9/7). FDA approved Seasonale, which allows users to reduce their number of annual menstrual periods from 13 to four, in September 2003. Women take 84 active pills consecutively and then take seven placebo pills, compared with the usual regimen of 21 active pills followed by seven placebos. The U.S. Patent and Trademark Office in May denied Barr's request to reissue its patent on Seasonale. Barr's subsidiary Duramed Pharmaceuticals received a nonfinal rejection notice from the patent office, which gave the company three months to reply to issues raised by the government before the company's three-year product exclusivity expired on Sept. 5 (Kaiser Daily Women's Health Policy Report, 5/15). Watson -- which in 2004 filed a marketing application with FDA saying that Duramed's Seasonale patent was unenforceable and void -- announced it will immediately launch its product, which will be sold under the name Quasense, MarketWatch reports. According to MarketWatch, Watson is the first pharmaceutical company to successfully challenge Barr's patent on Seasonale and will have market exclusivity for 180 days (Pritchard, MarketWatch, 9/7).
The Food and Drug Administration yesterday approved a new type of birth control pill that enables women to skip their monthly menstrual cycle for about three months.
The new pill, called Seasonale, should be available by prescription by the end of October, according to Barr Laboratories Inc. of Woodcliff Lake, N.J., which developed it.
Seasonale uses the same hormones in the same doses as most traditional birth control pills and so is considered equally safe. Standard birth control pills can increase the risk for blood clots, heart attacks and strokes, especially among women who smoke.
The difference is that each packet contains 84 hormone pills instead of 21, followed by seven placebo pills, so the reproductive process is suppressed for three months instead of three weeks.
Many women have been using traditional birth control pills that way anyway, either because they want to skip their period for a special event such as a wedding or a vacation or because they want to minimize their periods to avoid cramps, bloating, crying jags, anxiety and other problems.
In tests, Seasonale won praise from women who suffer from intense problems associated with their periods.
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