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Norgestimate, sold under the brand name Ortho Tri-Cyclen among others, is a progestin medication which is used in birth control pills for women and in menopausal hormone therapy. [ 1 ] [ 3 ] [ 4 ] [ 5 ] The medication is available in combination with an estrogen and is not available alone. [ 6 ]
In 1989, the FDA approved Ortho Cyclen containing the first new progestin (norgestimate) approved in over 20 years in the United States. In 1992, Ortho introduced Ortho Tri-Cyclen in the United States, which in 1996 became the first oral contraceptive with an FDA-approved non-contraceptive indication (treatment of moderate acne).
This is a list of progestogens (progesterone and progestins) and formulations that are approved by the FDA Tooltip Food and Drug Administration in the United States. . Progestogens are used as hormonal contraceptives, in hormone replacement therapy for menopausal symptoms, and in the treatment of gynecological
All contain an estrogen, ethinylestradiol or mestranol, [1] [2] in varying amounts, and one of a number of different progestogens. (Regarding the estrogen, the inactive 3-methyl ether of ethinylestradiol, which must be metabolized by the liver into the active ethinylestradiol; 50 μg of mestranol is equivalent to only 35 μg of ethinylestradiol and should not be used when high-dose [50 μg ...
These include Ortho Tri-Cyclen, Estrostep, Beyaz, and YAZ. [65] [66] [67] Hirsutism is the growth of coarse, dark hair where women typically grow only fine hair or no hair at all. [68] This hair growth on the face, chest, and abdomen is also mediated by higher levels or action of androgens.
The Generic Product Identifier (GPI) is a 14-character hierarchical classification system created by Wolters Kluwer's Medi-Span that identifies drugs from their primary therapeutic use down to the unique interchangeable product regardless of manufacturer or package size. The code consists of seven subsets, each providing increasingly more ...
Norelgestromin is available only as a transdermal contraceptive patch in combination with ethinyl estradiol. [6] The Ortho Evra patch is a 20 cm 2, once-weekly adhesive that contains 6.0 mg norelgestromin and 0.6 mg ethinyl estradiol and delivers 200 μg/day norelgestromin and 35 μg/day ethinyl estradiol.
In 2010, Ortho-McNeil pled guilty in U.S. District Court to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was charged with using a program called "Doctor for a Day" to promote Topamax to psychiatrists for treatment of ...