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

Drugs Approved in 2013

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