Approved Drugs for Obstetrics/Gynecology
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
Elestrin (estradiol gel); BioSante;
For the treatment of vasomotor symptoms associated with menopause, Approved December 2006
EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals;
For the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, Approved April 2004
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
Bextra; Pharmacia, Pfizer;
Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001
Femara (letrozole) Tablets; 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
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; Novartis;
For the prevention of postmenopausal osteoporosis, Approved August 2000
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; 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-Ayerst Laboratories;
Transdermal patch system for the treatement of vulvar vaginal atrophy and vasomotor symptoms., Approved September 1999
Evista; Eli Lilly;
Osteoporosis treatment, Approved September 1999
Femhrt Tablets; Parke-Davis;
Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999
Lupron Depot; 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
Cleocin Vaginal Cream 2%; 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; Boehringer Ingelheim;
Treatment for Hypertension, Approved November 1998
Mircette; Organon;
Oral contraceptive, Approved April 1998
Prempro; Wyeth-Ayerst Laboratories;
Treatment for hormone replacement therapy, Approved January 1998
PREVEN ; Emergency Contraceptive Kit; Gynetics;
Emergency Contraceptive Pills, Approved September 1998
Prometrium; Schering;
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
Alesse (100 mcg levonorgestrel/20 mcg ethinyl estradiol tablets); Wyeth-Ayerst Laboratories;
Treatment for the prevention of pregnancy, Approved April 1997
Crinone 8% (progesterone gel); Wyeth-Ayerst Laboratories;
Treatment for infertile women with pregestone deficiency, Approved May 1997
Estradiol; Duramed Pharmaceuticals;
Generic equivalent of Estrace tablets, Approved December 1997
Estradiol Tablets USP; Barr Laboratories;
Generic equivalent of Estrace, Approved October 1997
Estrostep; Warner-Lambert;
Treatment for oral contraception, Approved March 1997
Evista; Eli Lilly;
Treatment for the prevention of osteoporosis, Approved December 1997
Femara; 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 Pharma Radiopharmaceuticals;
Test for breast cancer, Approved May 1997
Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol); Ortho 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
Aredia (pamidronate disodium for injection); Chiron Therapeutics, Ciba Pharmaceuticals;
Treatment for osteolytic bone metastases of breast cancer, Approved August 1996
Arimidex (anastrozole); Zeneca Pharmaceuticals;
Treatment for advanced breast cancer in postmenopausal women, Approved January 1996
Estrostep; 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
Ethyol (amifostine); Alza, U.S. Bioscience;
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-Ayerst Laboratories;
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