MORRISTOWN, N.J. — Watson Pharmaceuticals next year plans to roll out a chewable, low-dose oral contraceptive that the company called a new option for birth control.
The company said this week that it has gaind Food and Drug Administration approval for the product, which the drug maker said is the first and only low-dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets.
Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy, according to Watson. The company said the contraceptive is a novel alternative to currently available birth control pills. The tablet’s unique dosing combination and proven 24-day, active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.
"The approval of this oral contraceptive further strengthens Watson’s robust and expanding branded women’s health portfolio," stated Fred Wilkinson, executive vice president of global brands at Watson. "We believe this product is an important addition to the oral contraceptive category, and that its characteristics will make it a desirable choice for women."
The contraceptive product, licensed from a subsidiary of Warner Chilcott, is slated to be actively marketed to physicians by Watson’s Global Brands division beginning in the second quarter of 2011.
