List of progestogens available in the United States

Last updated

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 disorders.[ medical citation needed ]

Contents

For contraception

Combined contraceptives

Combined oral contraceptive pills

  • Drospirenone and Estetrol (Nextstellis)
  • Estradiol valerate and dienogest (Natazia)
  • Ethinylestradiol and desogestrel (Bekyree, Cyclessa, Desogen, Emoquette, Enskyce, Isibloom, Kariva, Kimidess, Mircette, Ortho-Cept, Pimtrea, Velivet, Viorele, Volnea)
  • Ethinylestradiol and drospirenone [and/or levomefolate calcium] (Beyaz, Loryna, Melamisa, Nikki, Safyral, Syeda, Yaela, Yasmin, Yaz)
  • Ethinylestradiol and etynodiol diacetate (Demulen 1/35-21, Demulen 1/35-28, Demulen 1/50-21, Demulen 1/50-28, Kelnor, Zovia 1/35E-21, Zovia 1/35E-28, Zovia 1/50E-21, Zovia 1/50E-28)
  • Ethinylestradiol and levonorgestrel (Alesse, Altavera, Ashlyna, Aviane-21, Aviane-28, Ayuna, Daysee, Elifemme, Enpresse-21, Enpresse-28, Falmina, Fayosim, Introvale, Kurvelo, Lessina-21, Lessina-28, Levlite, Levonest, Levonorgestrel and Ethinyl Estradiol, Levora 0.15/30-21, Levora 0.15/30-28, LoSeasonique, Lybrel, Marlissa, Myzilra, Nordette-21, Nordette-28, Orsythia, Portia-21, Portia-28, Preven Emergency Contraceptive Kit, Quartette, Quasense, Seasonale, Seasonique, Setlakin, Triphasil-21, Triphasil-28, Trivora-21, Trivora-28, Vienva)
  • Ethinylestradiol and norethisterone [and/or ferrous fumarate (Fe)] (Alyacen 1/35, Alyacen 7/7/7, Alyacen 777, Aranelle, Balziva-21, Balziva-28, Brevicon 21-Day, Brevicon 28-Day, Briellyn, Cyclafem 0.5/35, Cyclafem 1/35, Cyclafem 7/7/7, Dasetta 1/35, Dasetta 7/7/7, Femcon Fe, Gencept 10/11-21, Gencept 10/11-28, Gildagia, Kaitlib Fe, Modicon 21, Modicon 28, N.E.E. 1/35 21, N.E.E. 1/35 28, Norcept-E 1/35 21, Norcept-E 1/35 28, Norethin 1/35E-21, Norethin 1/35E-28, Norinyl 1+35 21-Day, Norinyl 1+35 28-Day, Norquest Fe, Nortrel 0.5/35-21, Nortrel 0.5/35-28, Nortrel 1/35-21, Nortrel 1/35-28, Nortrel 7/7/7, Ortho-Novum 1/35-21, Ortho-Novum 1/35-28, Ortho-Novum 10/11-21, Ortho-Novum 10/11-28, Ortho-Novum 7/14-21, Ortho-Novum 7/14-28, Ortho-Novum 7/7/7-21, Ortho-Novum 7/7/7-28, Ovcon-35, Ovcon-50, Philith, Pirmella 1/35, Pirmella 7/7/7, Tri-Norinyl 21-Day, Tri-Norinyl 28-Day, Vyfemla, Wera)
  • Ethinylestradiol and norethisterone acetate [and/or ferrous fumarate (Fe)] (Activella, Alyacen 1/35, Alyacen 7/7/7, Alyacen 777, Amabelz, Aranelle, Aurovela 1.5/30, [1] Aurovela 1/20, [2] Aurovela 24 Fe, [3] Aurovela Fe 1.5/30, [4] Aurovela Fe 1/20, [5] Aurovela Fe, [6] Aygestin, Balziva-21, Balziva-28, Blisovi 24 Fe, [7] Blisovi Fe 1.5/30, [8] Blisovi Fe 1/20, [9] Brevicon 21-Day, Brevicon 28-Day, Briellyn, Camila, Chabelina Fe, [10] Charlotte 24 Fe, [11] Combipatch, Cyclafem 0.5/35, Cyclafem 1/35, Cyclafem 7/7/7, Cyonanz, Dasetta 1/35, Dasetta 7/7/7, Errin, Estrostep 21, [12] Estrostep Fe, [13] Femcon Fe, Femhrt, [14] Finzala, [15] Fyavolv, [16] Gemmily, [17] Gencept 10/11-21, Gencept 10/11-28, Gildagia, Gildess 1.5/30, [18] Gildess 1/20, [19] Gildess 24 Fe, [20] Gildess Fe 1.5/30, [21] Gildess Fe 1/20, [22] Hailey 1.5/30, [23] Hailey 24 Fe, [24] Hailey Fe 1.5/30, [23] Hailey Fe 1/20, [25] Heather, Incassia, Jencycla, Jinteli, [26] Junel 1.5/30, [27] Junel 1/20, Junel 21, [28] Junel Fe 1.5/30, [27] Junel Fe 1/20, [29] Junel Fe 24, [30] Junel Fe 28, [28] Kaitlib Fe, Larin 1.5/30, [31] Larin 1/20, [32] Larin 24 Fe, [33] Larin Fe 1.5/30, [34] Larin Fe 1/20, [35] Leribane, Lo Larin Fe, Lo Loestrin Fe, [36] Lo Minastrin Fe, Lo-Blisovi Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 21, [37] Loestrin 24 Fe, [38] Loestrin Fe 1.5/30, Loestrin Fe 1/20, Loestrin Fe 28, [37] Lomedia 24 Fe, [39] Lupaneta Pack, Melodetta 24 Fe, [40] Merzee, [41] Mibelas 24 Fe, Microgestin 1.5/30, Microgestin 1/20, Microgestin Fe 1.5/30, Microgestin Fe 1/20, Micronor, Minastrin 24 Fe, Modicon 21, Modicon 28, Myfembree, N.E.E. 1/35 21, N.E.E. 1/35 28, Nexesta Fe, Nor-Qd, Norcept-E 1/35 21, Norcept-E 1/35 28, Norethin 1/35E-21, Norethin 1/35E-28, Norethin 1/50M-21, Norethin 1/50M-28, Norinyl, Norinyl 1+35 21-Day, Norinyl 1+35 28-Day, Norinyl 1+50 21-Day, Norinyl 1+50 28-Day, Norinyl 1+80 21-Day, Norinyl 1+80 28-Day, Norlestrin 21 1/50, Norlestrin 21 2.5/50, Norlestrin 28 1/50, Norlestrin Fe 1/50, Norlestrin Fe 2.5/50, Norlutate, Norlutin, Norminest Fe, Norquest Fe, Nortrel 0.5/35-21, Nortrel 0.5/35-28, Nortrel 1/35-21, Nortrel 1/35-28, Nortrel 7/7/7, Nylia 1/35, Nylia 7/7/7, Oriahnn (Copackaged), Ortho-Novum 1/35-21, Ortho-Novum 1/35-28, Ortho-Novum 1/50 21, Ortho-Novum 1/50 28, Ortho-Novum 1/80 21, Ortho-Novum 1/80 28, Ortho-Novum 2-21, Ortho-Novum 7/7/7-21, Ortho-Novum 7/7/7-28, Ortho-Novum 7/14-21, Ortho-Novum 7/14-28, Ortho-Novum 10-21, Ortho-Novum 10/11-21, Ortho-Novum 10/11-28, Ovcon-35, Ovcon-50, Philith, Pirmella 1/35, Pirmella 7/7/7, Taytulla, Tri-Legest 21, Tri-Legest 21 , Tri-Legest Fe, Tri-Norinyl 21-Day, Tri-Norinyl 28-Day, Vyfemla, Wera)
  • Ethinylestradiol and norgestimate (Estarylla, Mili, Mono-Linyah, Ortho Cyclen-21, Ortho Cyclen-28, Ortho Tri-Cyclen, Ortho Tri-Cyclen 21, Ortho Tri-Cyclen 28, Ortho Tri-Cyclen Lo, Previfem, Sprintec, Tri Lo Sprintec, Tri-Estarylla, Tri-Linyah, Tri-Lo-Estarylla, Tri-Lo-Linyah, Tri-Mili, Tri-Previfem, Tri-Sprintec)
  • Ethinylestradiol and norgestrel (Cryselle, Elinest, Lo/Ovral, Lo/Ovral-28, Low-Ogestrel-21, Low-Ogestrel-28, Ogestrel 0.5/50-21, Ogestrel 0.5/50-28, Ovral, Ovral-28)
  • Mestranol and norethisterone (Norinyl 1+50 28-Day)

Transdermal patches

Vaginal rings

Combined injectable contraceptives

Estradiol cypionate and medroxyprogesterone acetate (Lunelle; 5 mg / 25 mg) was previously available in the U.S. but was discontinued.

Progestogen-only contraceptives

Progestogen-only pills

  • Drospirenone (Slynd) – 4 mg (available as of 2019) [42]
  • Norethisterone (Camila, Errin, Heather, Incassia, Jencycla, Micronor, Nor-QD) – 0.35 mg
  • Norgestrel (Opill) – 0.075 mg (available over-the-counter as of 2023) [43]

Norgestrel (Ovrette; 0.075 mg) was also previously available in the U.S. as a prescription, but was discontinued in 2005 due to "marketing reasons". [44]

Postcoital emergency contraceptive pills

  • Levonorgestrel (Athentia Next, Fallback Solo, Her Style, Opcicon One-Step, Plan B, Plan B One-Step) – 0.75 mg, 1.5 mg

Progestogen-only injectable contraceptives

Intrauterine devices

  • Levonorgestrel (Kyleena, Liletta, Mirena, Skyla) – 13.5 mg/device, 19.5 mg/device, 52 mg/device

Progesterone (Progestasert; 38 mg/device) was previously available in the U.S. but was discontinued.

Subcutaneous implants

  • Etonogestrel (Implanon, Nexplanon) – 68 mg/implant
  • Levonorgestrel (Jadelle, Norplant, Norplant System in Plastic Container) – 36 mg/implant, 75 mg/implant

For other uses

Combined with estrogen

Oral pills

Estradiol/progesterone (TX-001HR), a combination of estradiol and progesterone in oil-filled capsules, is currently pending approval. [45]

Estradiol and norgestimate (Prefest; 1 mg / 90 μg) was previously available in the U.S. but was discontinued.

Transdermal patches

Progestogen-only

Oral pills

Atypical:

  • Danazol (Danocrine) – 50 mg, 100 mg, 200 mg – approved specifically for the treatment of endometriosis

Oral suspensions

Vaginal tablets

Vaginal gels

Intramuscular injectables

Miscellaneous

Not available in the United States

See also

Related Research Articles

<span class="mw-page-title-main">Desogestrel</span> Medication

Desogestrel is a progestin medication which is used in birth control pills for women. It is also used in the treatment of menopausal symptoms in women. The medication is available and used alone or in combination with an estrogen. It is taken by mouth.

<span class="mw-page-title-main">Drospirenone</span> Medication drug

Drospirenone is a progestin and antiandrogen medication which is used in birth control pills to prevent pregnancy and in menopausal hormone therapy, among other uses. It is available both alone under the brand name Slynd and in combination with an estrogen under the brand name Yasmin among others. The medication is an analog of the drug spironolactone. Drospirenone is taken by mouth.

<span class="mw-page-title-main">Norethisterone acetate</span> Chemical compound

Norethisterone acetate (NETA), also known as norethindrone acetate and sold under the brand name Primolut-Nor among others, is a progestin medication which is used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. The medication available in low-dose and high-dose formulations and is used alone or in combination with an estrogen. It is ingested orally.

<span class="mw-page-title-main">Norelgestromin</span> Pharmaceutical drug

Norelgestromin, or norelgestromine, sold under the brand names Evra and Ortho Evra among others, is a progestin medication which is used as a method of birth control for women. The medication is available in combination with an estrogen and is not available alone. It is used as a patch that is applied to the skin.

<span class="mw-page-title-main">Norgestimate</span> Chemical compound

Norgestimate, sold under the brand names Ortho Tri-Cyclen and Previfem among others, is a progestin medication which is used in birth control pills for women and in menopausal hormone therapy. The medication is available in combination with an estrogen and is not available alone. It is taken by mouth.

Ethinylestradiol/norethisterone acetate (EE/NETA), or ethinylestradiol/norethindrone acetate, is a combination of ethinylestradiol (EE) and norethisterone acetate (NETA) which is used as birth control and menopausal hormone therapy. EE is an estrogen, while norethisterone acetate (NETA) is a progestin. It is taken by mouth. Some preparations of EE/NETA used in birth control additionally contain an iron supplement in the form of ferrous fumarate.

<span class="mw-page-title-main">Etynodiol diacetate</span> Chemical compound

Etynodiol diacetate, or ethynodiol diacetate, sold under the brand name Ovulen among others, is a progestin medication which is used in birth control pills. The medication is available only in combination with an estrogen. It is taken by mouth.

<span class="mw-page-title-main">Norethisterone</span> Progestin medication

Norethisterone, also known as norethindrone and sold under many brand names, is a progestin medication used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. The medication is available in both low-dose and high-dose formulations and both alone and in combination with an estrogen. It is used by mouth or, as norethisterone enanthate, by injection into muscle.

<span class="mw-page-title-main">Mestranol</span> Chemical compound

Mestranol, sold under the brand names Enovid, Norinyl, and Ortho-Novum among others, is an estrogen medication which has been used in birth control pills, menopausal hormone therapy, and the treatment of menstrual disorders. It is formulated in combination with a progestin and is not available alone. It is taken by mouth.

Estradiol/norethisterone acetate (E2/NETA), sold under the brand name Activella among others, is a combination of estradiol (E2) and norethisterone acetate (NETA) which is used in the treatment of vasomotor symptoms, vulvar and vaginal atrophy, and osteoporosis associated with menopause. Activella specifically is marketed by Novo Nordisk and is supplied as film-coated tablets containing 1 mg estradiol and 0.5 mg norethisterone acetate. CombiPatch is a combination of estradiol and NETA provided as a transdermal patch.

Birth control pills come in a variety of formulations. The main division is between combined oral contraceptive pills, containing both estrogens and synthetic progestogens (progestins), and progestogen only pills. Combined oral contraceptive pills also come in varying types, including varying doses of estrogen, and whether the dose of estrogen or progestogen changes from week to week.

Naari Pharma Pvt. Ltd. is a pharmaceutical company based in Bengaluru, India. Naari was founded on December 17, 2007. The company is involved in manufacturing of Active pharmaceutical ingredients and Finished Formulations, focusing on the female health segment with an emphasis on high active female hormones.

<span class="mw-page-title-main">Norethisterone enanthate</span> Chemical compound

Norethisterone enanthate (NETE), also known as norethindrone enanthate, is a form of hormonal birth control which is used to prevent pregnancy in women. It is used both as a form of progestogen-only injectable birth control and in combined injectable birth control formulations. It may be used following childbirth, miscarriage, or abortion. The failure rate per year in preventing pregnancy for the progestogen-only formulation is 2 per 100 women. Each dose of this form lasts two months with only up to two doses typically recommended.

Ethinylestradiol/norethisterone (EE/NET), or ethinylestradiol/norethindrone, is a combination birth control pill which contains ethinylestradiol (EE), an estrogen and norethisterone (NET), a progestin. It is used for birth control, symptoms of menstruation, endometriosis, and menopausal symptoms. Other uses include acne. It is taken by mouth. Some preparations of EE/NET additionally contain an iron supplement in the form of ferrous fumarate.

Norelgestromin/ethinylestradiol, sold under the brand name Ortho Evra among others, is a contraceptive patch containing the progestin norelgestromin and the estrogen ethinylestradiol.

Mestranol/norethisterone is a combination of the estrogen ethinylestradiol and the progestin norethisterone (norethindrone) which was introduced in 1963 and was the second combined oral contraceptive to be marketed, following mestranol/noretynodrel in 1960. Although most mestranol-containing oral contraceptive formulations have been discontinued, the combination remains available today in the United States in a single formulation under the brand name Norinyl 1+50 28-Day. It has largely been superseded by ethinylestradiol/norethisterone, which has been marketed under many of the same brand names.

<span class="mw-page-title-main">Segesterone acetate/ethinylestradiol</span> Combination hormonal birth control

Segesterone acetate/ethinylestradiol (EE/SGA), sold under the brand name Annovera, is a contraceptive vaginal ring and combined form of hormonal birth control which contains segesterone acetate, a progestin and ethinylestradiol, an estrogen. It contains 17.4 mg ethinylestradiol and 103 mg segesterone acetate, releases an average of 13 μg ethinylestradiol and 0.15 mg segesterone acetate per day.

<span class="mw-page-title-main">Relugolix/estradiol/norethisterone acetate</span> Combination medication

Relugolix/estradiol/norethisterone acetate, sold under the brand names Myfembree and Ryeqo, is a fixed-dose combination hormonal medication which is used for the treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and for moderate to severe pain associated with endometriosis. It contains relugolix, an orally active gonadotropin-releasing hormone antagonist, estradiol, an estrogen, and norethisterone acetate, a progestin. The medication is taken by mouth.

References

  1. ↑ "Aurovela 1.5/30- norethindrone acetate and ethinyl estradiol tablet". DailyMed.
  2. ↑ "Aurovela 1/20- norethindrone acetate and ethinyl estradiol tablet". DailyMed.
  3. ↑ "Aurovela 24 FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  4. ↑ "Aurovela Fe 1.5/30: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA).
  5. ↑ "Aurovela FE 1/20- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  6. ↑ "Aurovela FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  7. ↑ "Blisovi 24 FE- norethindrone acetate and ethinyl estradiol kit". DailyMed.
  8. ↑ "Blisovi FE 1.5/30- norethindrone acetate and ethinyl estradiol kit". DailyMed.
  9. ↑ "Blisovi FE 1/20- norethindrone acetate and ethinyl estradiol kit". DailyMed.
  10. ↑ "Chabelina Fe: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA).
  11. ↑ "Charlotte 24FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  12. ↑ "Estrostep 21: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA).
  13. ↑ "Estrostep FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  14. ↑ "Femhrt- norethindrone acetate/ethinyl estradiol tablet". DailyMed.
  15. ↑ "Finzala: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA).
  16. ↑ "Fyavolv- norethindrone acetate and ethinyl estradiol tablet, film coated". DailyMed.
  17. ↑ "Gemmily- norethindrone acetate and ethinyl estradiol, and ferrous fumarate kit". DailyMed.
  18. ↑ "Gildess 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP)". DailyMed.
  19. ↑ "Gildess 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP)". DailyMed.
  20. ↑ "Gildess 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP)". DailyMed.
  21. ↑ "Gildess Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP)". DailyMed.
  22. ↑ "Gildess Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP)". DailyMed.
  23. 1 2 "Hailey FE 1.5/30- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  24. ↑ "Hailey 24 FE- norethindrone acetate and ethinyl estradiol, and ferrous fumarate kit". DailyMed.
  25. ↑ "Hailey FE 1/20- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  26. ↑ "Jinteli- norethindrone acetate and ethinyl estradiol tablet". DailyMed.
  27. 1 2 "Junel FE 1.5/30- norethindrone acetate and ethinyl estradiol, and ferrous fumarate kit". DailyMed.
  28. 1 2 "Junel 21 DAY- norethindrone acetate and ethinyl estradiol tablet JUNEL FE 28 DAY- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  29. ↑ "Junel FE 1/20- norethindrone acetate and ethinyl estradiol, and ferrous fumarate kit". DailyMed.
  30. ↑ "Junel FE 24- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  31. ↑ "Larin 1.5/30- norethindrone acetate/ethinyl estradiol kit". DailyMed.
  32. ↑ "Larin 1/20- norethindrone acetate/ethinyl estradiol kit". DailyMed.
  33. ↑ "Larin 24 FE- norethindrone acetate/ethinyl estradiol and ferrous fumarate kit". DailyMed.
  34. ↑ "Larin FE 1.5/30- norethindrone acetate/ethinyl estradiol and ferrous fumarate kit". DailyMed.
  35. ↑ "Larin FE 1/20- norethindrone acetate/ethinyl estradiol and ferrous fumarate kit". DailyMed.
  36. ↑ "Lo Loestrin FE- norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate kit". DailyMed.
  37. 1 2 "Loestrin 21 DAY- norethindrone acetate and ethinyl estradiol tablet Loestrin FE 28 DAY- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  38. ↑ "Loestrin 24 FE- norethindrone acetate and ethinyl estradiol, and ferrous fumarate kit". DailyMed.
  39. ↑ "Lomedia 24 FE- norethindrone acetate and ethinyl estradiol kit". DailyMed.
  40. ↑ "Melodetta 24 FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  41. ↑ "Merzee- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit". DailyMed.
  42. ↑ Brian Park, PharmD (16 September 2019). "Slynd, a Progestin-Only Contraceptive, Now Available". Monthly Prescribing Reference (MPR). Haymarket Media, Inc. Retrieved 5 January 2020.
  43. ↑ Commissioner, Office of the (2023-07-13). "FDA Approves First Nonprescription Daily Oral Contraceptive". FDA. Retrieved 2024-03-17.
  44. ↑ Murry, Karen (July 13, 2023). "Decisional Memorandum New Drug Application 17031 Supplement 41 Application for Full Prescription-to-Nonprescription Switch of Norgestrel Tablets 0.075 mg" (PDF). FDA.
  45. ↑ Pickar JH, Bon C, Amadio JM, Mirkin S, Bernick B (2015). "Pharmacokinetics of the first combination 17β-estradiol/progesterone capsule in clinical development for menopausal hormone therapy". Menopause. 22 (12): 1308–16. doi:10.1097/GME.0000000000000467. PMC   4666011 . PMID   25944519.
  46. ↑ Jame Abraham; James L. Gulley; Carmen J. Allegra (1 September 2009). Bethesda Handbook of Clinical Oncology. Lippincott Williams & Wilkins. pp. 612–. ISBN   978-0-7817-9558-6.
  47. ↑ Guido Eibl; Mouad Edderkaoui (22 April 2015). Risk Factors for Pancreatic Cancer: Underlying Mechanisms and Potential Targets. Frontiers Media SA. pp. 96–. ISBN   978-2-88919-468-1. In 1993, the Food and Drug Administration (FDA) approved megestrol acetate for the treatment of cancer anorexia-cachexia syndrome as well as cachexia due to chronic conditions, including human acquired immunodeficiency syndrome (AIDS).
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