Glenmark Generics Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for the oral contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.09 mg/0.02 mg, the therapeutic equivalent of Lybrel® of Wyeth Pharmaceuticals, Inc.
Glenmark Generics Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for the oral
contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.09 mg/0.02 mg, the therapeutic equivalent of Lybrel®of Wyeth Pharmaceuticals, Inc. (which is no longer being marketed in the United States).
Lybrel® is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health sales data for the 12 month period ending February 2015, the Lybrel® market achieved annual sales of approximately $6.4 million.
Today’s approval marks Glenmark’s 11th oral contraceptive authorized for distribution by the U.S.FDA. Glenmark plans to commence shipping of Levonorgestrel/Ethinyl Estradiol Tablets, 0.09 mg/0.02 mg immediately.
Glenmark’s current portfolio consists of 97 products authorized for distribution in the U.S. marketplace and 68 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.09 mg/0.02 mg, the therapeutic equivalent of Lybrel®of Wyeth Pharmaceuticals, Inc. (which is no longer being marketed in the United States).
Lybrel® is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health sales data for the 12 month period ending February 2015, the Lybrel® market achieved annual sales of approximately $6.4 million.
Today’s approval marks Glenmark’s 11th oral contraceptive authorized for distribution by the U.S.FDA. Glenmark plans to commence shipping of Levonorgestrel/Ethinyl Estradiol Tablets, 0.09 mg/0.02 mg immediately.
Glenmark’s current portfolio consists of 97 products authorized for distribution in the U.S. marketplace and 68 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
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