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FDA Approved Drugs by Therapeutic Area

Search by therapeutic area for drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Click on an area below to view the complete list of drugs in that category or review descriptions for our therapeutic area list to assist you in your search.

Find out more about the types of drugs included in this listing.

FDA Approved Drugs for Obstetrics/Gynecology (Women’s Health)

Drugs Approved in 2014

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Drugs Approved in 2013

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013

Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For the treatment of nausea and vomiting of pregnancy, Approved April 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 2013

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate); Warner Chilcott; For the prevention of pregnancy, Approved July 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013

Drugs Approved in 2012

Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012

Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; For the treatment of heavy menstrual bleeding, Approved March 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Drugs Approved in 2011

Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved February 2011

Drugs Approved in 2010

ella (ulipristal acetate); HRA Pharma; For the emergency prevention of contraception, Approved August 2010

Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010

Natazia (estradiol valerate + dienogest); Bayer; For the prevention of contraception, Approved May 2010

Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010

Drugs Approved in 2009

Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant; GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, Approved October 2009

Lysteda (tranexamic acid); Xanodyne Pharmaceuticals; For the treatment of heavy menstrual bleeding, Approved November 2009

Drugs Approved in 2007

Evamist (estradiol); Vivus; For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved July 2007

Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007

Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis, Approved August 2007

Drugs Approved in 2006

Elestrin (estradiol gel); BioSante; For the treatment of vasomotor symptoms associated with menopause, Approved December 2006

Drugs Approved in 2004

EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals; For the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, Approved April 2004

Drugs Approved in 2003

Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003

Seasonale, Lo Seasonale, Seasonique (ethinylestradiol + levonorgestrel); Duramed Pharmaceuticals; For the prevention of contraception, Approved September 2003

Drugs Approved in 2002

Alora; Watson Pharmaceuticals; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002

Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals; Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002

Forteo (teriparatide); Eli Lilly; For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002

Vivelle-Dot (estradiol transdermal system); Novartis; For the prevention of post-menopausal osteoporosis, Approved May 2002

Zoloft (sertraline HCl); Pfizer; Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD), Approved May 2002

Drugs Approved in 2001

Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Monistat 3 (miconazole nitrate); Advanced Care Products; Emulsion, cream for the treatment of vaginal yeast infections, Approved February 2001

NuvaRing; Organon; Monthly vaginal ring for birth control, Approved October 2001

Ortho Evra; Ortho-McNeil Pharmaceutical; Transdermal patch for contraception, Approved November 2001

Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001

Drugs Approved in 2000

Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause, Approved April 2000

Cetrotide; Asta Medica; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation, Approved August 2000

Mirena (levonorgestrel-releasing intrauterine system); Berlex Laboratories; Hormone-releasing system for intrauterine contraception, Approved December 2000

Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the induction of final follicular maturation and early luteinization in infertile women, Approved September 2000

Trivagizole 3 (clotrimazole) Vaginal Cream; Taro Pharmaceuticals; For the treatment of vaginal yeast infections, Approved April 2000

Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal osteoporosis, Approved August 2000

Drugs Approved in 1999

Aromasin Tablets; Pharmacia & Upjohn; Exemestane Tablets, 25 mg, October 21, 1999

Cenestin; Duramed Pharmaceuticals; Treatment for relief of vasomotor symptoms due to menopause, Approved March 1999

Cenestin; Duramed Pharmaceuticals; Treatment for symptoms associated with menopause, Approved July 1999

Cleocin (clindamycin phosphate); Pharmacia & Upjohn; Treatment for bacterial vaginosis, Approved August 1999

Climara; Berlex Laboratories; For the prevention of postmenopausal osteoporosis (loss of bone mass), Approved June 1999

Doxil (doxorubicin HCl liposome injection); Alza; Treatment for ovarian cancer that is refractory to other first-line therapies, Approved June 1999

Ellence; Pharmacia & Upjohn; epirubicin hydrochloride, Approved September 1999

Estradiol Transdermal System; Wyeth; Transdermal patch system for the treatement of vulvar vaginal atrophy and vasomotor symptoms., Approved September 1999

Evista (raloxifene hydrochloride); Eli Lilly; Osteoporosis treatment, Approved September 1999

Femhrt Tablets; Parke-Davis; Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999

Lupron Depot (leuprolide acetate for depot suspension); TAP Pharmaceuticals; Treatment for endometriosis and uterine fibroids, Approved June 1999

Ortho-Prefest; Ortho-McNeil Pharmaceutical, RW Johnson; 17 beta estradiol/17 beta estradiol norgestimate tablets, October 22, 1999

Tequin; Bristol-Myers Squibb; Tequin (Injectable and Tablet), December, 1999

Drugs Approved in 1998

Cleocin (clindamycin phosphate); Pharmacia & Upjohn; Treatment for bacterial vaginosis, Approved March 1998

Esclim; Fournier Research; Treatment for symptoms associated to Menopause, Approved August 1998

Estratab (.3 mg ); Solvay Pharmaceuticals; Treatment for the prevention of osteoporosis, Approved March 1998

Herceptin; Genentech; Treatment for metastatic breast cancer, Approved October 1998

Inform HER-2/neu breast cancer test; Oncor; Treatment for breast cancer prediction, Approved January 1998

Micardis (telmisartan); Boehringer Ingelheim; Treatment for Hypertension, Approved November 1998

Mircette; Organon; Oral contraceptive, Approved April 1998

Prempro; Wyeth; Treatment for hormone replacement therapy, Approved January 1998

PREVEN ; Emergency Contraceptive Kit; Gynetics; Emergency Contraceptive Pills, Approved September 1998

Prometrium; Schering-Plough; Treatment for Endometrial Hyperplasia, Approved December 1998

Prometrium; Solvay Pharmaceuticals; Treatment for amenorrhea (abnormal cessation of menses), Approved May 1998

Xeloda; Roche; Treatment for advanced breast cancer tumors, Approved April 1998

Drugs Approved in 1997

Alesse (100 mcg levonorgestrel/20 mcg ethinyl estradiol tablets); Wyeth; Treatment for the prevention of pregnancy, Approved April 1997

Crinone 8% (progesterone gel); Wyeth; Treatment for infertile women with pregestone deficiency, Approved May 1997

Estradiol tablets; Barr Laboratories; Generic equivalent of Estrace, Approved October 1997

Estradiol tablets; Duramed Pharmaceuticals; Generic equivalent of Estrace tablets, Approved December 1997

Estrostep (norethindrone acetate and ethinyl estradiol); Warner-Lambert; Treatment for oral contraception, Approved March 1997

Evista (raloxifene hydrochloride); Eli Lilly; Treatment for the prevention of osteoporosis, Approved December 1997

Femara (letrozole); Novartis; Treatment for breast cancer, Approved July 1997

FEMSTAT One; Roche; Treatment for vaginal yeast infections, Approved Februrary 1997

Flagyl ER; Searle; Treatment for bacterial vaginosis, Approved December 1997

Floxin Tablets (ofloxacin tablets); Ortho-McNeil Pharmaceutical; Treatment for pelvic inflammatory disease (PID), Approved January 1997

Follistim (TM) (follitropin beta for injection); Organon; Treatment for infertility, Approved September 1997

Gonal-F (follitropin alfa for injection); Serono Laboratories; Treatment for infertility, Approved September 1997

Miraluma test; DuPont Merck Pharmaceutical Company; Test for breast cancer, Approved May 1997

Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol); Ortho-McNeil Pharmaceutical; Treatment for acne in women seeking contraception, Approved January 1997

Trivora-21 and Trivora-28; Watson Pharmaceuticals; Generic equivalents of levonorgestrel and ethinyl estradiol, Approved December 1997

Drugs Approved in 1996

Aredia (pamidronate disodium for injection); Chiron; Treatment for osteolytic bone metastases of breast cancer, Approved August 1996

Arimidex (anastrozole); AstraZeneca; Treatment for advanced breast cancer in postmenopausal women, Approved January 1996

Estrostep (norethindrone acetate and ethinyl estradiol); Parke-Davis; Treatment for birth control, Approved October 1996

FemPatch; Parke-Davis; Treatment for menopausal symptoms, Approved December 1996

Fertinex (urofollitropin for injection, purified); Serono Laboratories; Treatment for patients undergoing infertility treatments, Approved September 1996

Hycamtin (topotecan hydrochloride); SmithKline Beecham; Treatment for metastatic ovarian cancer, Approved May 1996

Monistat 3 (miconazole nitrate); Johnson & Johnson; Over the counter treatment for vaginal yeast infections, Approved April 1996

Seprafilm; Genzyme; Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996

Taxotere (Docetaxel); Rhone Poulenc Rorer; Treatment for locally advanced or metastatic breast cancer, Approved May 1996

Vivelle (estradiol transdermal system); Ciba Pharmaceuticals; Treatment for moderate and severe vasomotor menopausal symptoms, Approved March 1996

Drugs Approved in 1995

Ethyol (amifostine); Alza; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer, Approved December 8, 1995

Femstat 3 (butoconazole nitrate 2%); Procter & Gamble, Roche; Over the counter treatment for vaginal yeast infections, Approved December 1995

Fosamax (alendronate sodium); Merck; Treatment for osteoporosis in women after menopause and Paget's Disease of Bone, Approved on September 29, 1995

Miacalcin (calcitonin-salmon) Nasal Spray; Sandoz Pharmaceuticals; Treatment for post-menopausal osteoporosis, Approved on August 17, 1995

Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Wyeth; Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis, Approved November 1995

Self-examination breast pad; Inventive Products; Self-examination breast pad, Approved on December 22, 1995

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