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news.Glenmark Generics Inc, a US based subsidiary of Glenmark Generics Ltd, has been granted final approval by the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) of Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets.
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Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets are the generic version of Ovcon 35 tablets by Warner Chilcott.
The product will be marketed under the trade name Briellyn and distribution is expected to start immediately.
Briellyn provides a continuous 28 day regimen for oral contraception derived from 21 tablets composed of Norethindrone and Ethinyl Estradiol to be followed by 7 inert tablets and is indicated for the prevention of pregnancy.
Reportedly, Glenmark remains the only Indian company to be granted ANDA approval for an oral contraceptive product and the current approval marks their fourth female hormonal product authorized for distribution by the FDA.