First-Time Generic Approvals: Procardia XL, Estrostep FE, Estrostep

Jill Taylor

December 07, 2007

December 7, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for nifedipine extended-release tablets in 90-mg strength for the management of angina and treatment of hypertension; norethindrone acetate and ethinyl estradiol tablets (28-day) in 1 mg/0.02 mg, 1 mg/0.03 mg, and 1 mg/0.035 mg strengths for the prevention of pregnancy and treatment of moderate acne vulgaris in females; and norethindrone acetate and ethinyl estradiol tablets (21-day) in 1 mg/0.02 mg, 1 mg/0.03 mg, and 1 mg/0.035 mg strengths for the prevention of pregnancy and treatment of moderate acne vulgaris in females.

Generic Nifedipine Extended-Release Tablets ( Procardia XL) for Angina and Hypertension

On October 3, the FDA approved the first generic formulation of nifedipine extended-release tablets (generic, Osmotica Pharmaceutical Corporation; comparable brand, Procardia XL, Pfizer, Inc) in 90-mg strength for the management of vasospastic angina (confirmed by classical pattern of angina at rest accompanied by ST segment elevation, angina or coronary artery spasm provoked by ergonovine, or angiographically demonstrated coronary artery spasm), management of chronic stable angina without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents, and the treatment of hypertension.

The contractile processes of cardiac muscle and vascular smooth muscle depend on the movement of extracellular calcium ions through specific channels. Nifedipine, a calcium channel blocker, prevents spasm by selectively inhibiting calcium ion influx across the cell membrane of cardiac and vascular smooth muscle and reduces arterial pressure by dilating peripheral arterioles and reducing the total peripheral vascular resistance that the heart works against.

Generic Norethindrone Acetate and Ethinyl Estradiol Tablets (28-Day) ( Estrostep FE) for Oral Contraception and Treatment of Acne Vulgaris

On October 26, the FDA approved the first generic formulation of norethindrone acetate and ethinyl estradiol tablets (28-day) (generic, Barr Laboratories, Inc; comparable brand, Estrostep FE, Parke-Davis) in 1 mg/0.02 mg, 1 mgt/0.03 mg, and 1 mg/0.035 mg strengths for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception, and for the treatment of moderate acne vulgaris in females 15 years of age or older who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.

Norethindrone acetate and ethinyl estradiol is a combination oral contraceptive that inhibits ovulation in women through suppression of gonadotropins — pituitary hormones that would otherwise stimulate the function of the ovaries. Although norethindrone acetate and ethinyl estradiol therapy decreases the level of testosterone, which contributes to acne by stimulating sebum production, the relationship between decreased androgen level and severity of facial acne in otherwise healthy women is yet unestablished.

Norethindrone acetate and ethinyl estradiol (28-day) provides estrogen in a graduated sequence with a constant dose of progestogen over a 21-day period, followed by 7 ferrous fumarate tablets, which facilitate the ease of administration during a 28-day regimen.

Generic Norethindrone Acetate and Ethinyl Estradiol Tablets (21-Day) ( Estrostep FE) for Oral Contraception and Treatment of Acne Vulgaris

On October 26, the FDA approved the first generic formulation of norethindrone acetate and ethinyl estradiol tablets (21-day) (generic, Barr Laboratories, Inc; comparable brand, Estrostep, Parke-Davis) in 1 mg/0.02 mg, 1 mg/0.03 mg, and 1 mg/0.035 mg strengths for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception, and for the treatment of moderate acne vulgaris in females 15 years of age or older who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.

Norethindrone acetate and ethinyl estradiol is a combination oral contraceptive that inhibits ovulation in women through suppression of gonadotropins — pituitary hormones that would otherwise stimulate the function of the ovaries. Although norethindrone acetate and ethinyl estradiol therapy decreases the level of testosterone, which contributes to acne by stimulating sebum production, the relationship between decreased androgen level and severity of facial acne in otherwise healthy women is yet unestablished.

Norethindrone acetate and ethinyl estradiol (21-day) provides estrogen in a graduated sequence with a constant dose of progestogen over a 21-day period during a 28-day regimen.

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