Watson chewable contraceptive approved

Published: 23 Dec 2010

The US Food and Drug Administration (FDA) has granted marketing clearance to a new chewable, low-dose oral contraceptive from Watson Pharmaceuticals. The product is the first and only low dose oral contraceptive to combine 0.8mg norethindrone and 0.025mg ethinyl estradiol in chewable form, according to the company.

The pill's dosing regimen, which includes 24 days of active hormones and four ferrous fumarate (iron) placebo tablets, is intended to give women a low level of breakthrough bleeding and short, light, predictable periods.

Watson, which has largely focused on generic drugs, licensed the product from a subsidiary of Warner Chilcott as part of its move to expand its branded offerings by forging partnerships with other companies. Under the licensing and supply agreement deal, which the companies signed in January 2009, Watson obtained an exclusive licence to market and sell the product, with Warner Chilcott agreeing to exclusively supply Watson with the drug on a cost-plus-margin basis in return for royalties based on net sales.

Watson plans to begin marketing the product to physicians through its Global Brands division beginning in the second quarter of 2011. 

The new drug application for the product included data from a 12-month, open-label phase III study that enrolled 1,251 women between the ages of 18 and 35. The data showed the drug prevented pregnancy and that the women had short, predictable periods, with a mean duration of 3.7 days, according to Watson.  

The product is not the first chewable birth control pill to hit the US market: Bristol Myers Squibb's Ovcon 35, a spearmint-flavored chewable contraceptive marketed by Warner Chilcott was approved by the FDA in 2003, and Warner Chilcott launched a similar product called Femcon Fe in 2006.

Published: 23 Dec 2010

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