Approved Drugs for Obstetrics/Gynecology

Drugs Approved in 2008

Drugs Approved in 2007

• Evamist (estradiol); For the treatment of moderate to severe vasomotor symptoms due to menopause; Vivus; Approved July 2007
• Evista (raloxifene hydrochloride); For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women; Eli Lilly; Approved September 2007
• Reclast (zoledronic acid); For the treatment of postmenopausal osteoporosis; Novartis; Approved August 2007

Drugs Approved in 2006

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

Drugs Approved in 2005

Drugs Approved in 2004

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

Drugs Approved in 2003

Drugs Approved in 2002

• Alora; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms; Watson Pharmaceuticals; Approved April 2002
• Bravelle (urofollitropin for injection, purified); Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility.; Ferring Pharmaceuticals; Approved May 2002
• Forteo (teriparatide); For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture.; Eli Lilly; December 2002
• Vivelle-Dot (estradiol transdermal system); For the prevention of post-menopausal osteoporosis; Novartis; Approved May 2002
• Zoloft (sertraline HCl); Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD); Pfizer; Approved May 2002

Drugs Approved in 2001

• Bextra; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain; Pharmacia, Pfizer; Approved November 2001
• Femara (letrozole) Tablets; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer; Novartis; Approved January 2001
• Invanz; Once-daily injectable treatment for bacterial infections; Merck; Approved November 2001
• Monistat 3 (miconazole nitrate); Emulsion, cream for the treatment of vaginal yeast infections; Advanced Care Products; Approved February 2001
• NuvaRing; Monthly vaginal ring for birth control; Organon; Approved October 2001
• Ortho Evra; Transdermal patch for contraception; Ortho-McNeil Pharmaceutical; Approved November 2001
• Yasmin (drospirenone/ethinyl estradiol); Oral contraceptive; Berlex Laboratories; Approved May 2001

Drugs Approved in 2000

• Activella (Estradiol/Norethindrone Acetate) Tablets; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause; Novo Nordisk; Approved April 2000
• Cetrotide; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation; Asta Medica; Approved August 2000
• Mirena (levonorgestrel-releasing intrauterine system); Hormone-releasing system for intrauterine contraception; Berlex Laboratories; Approved December 2000
• Ovidrel (gonadotropin, chorionic human recombinant); For the induction of final follicular maturation and early luteinization in infertile women; Serono Laboratories; Approved September 2000
• Trivagizole 3 (clotrimazole) Vaginal Cream; For the treatment of vaginal yeast infections; Taro Pharmaceuticals; Approved April 2000
• Vivelle; For the prevention of postmenopausal osteoporosis; Novartis; Approved August 2000

Drugs Approved in 1999

• Aromasin Tablets; Exemestane Tablets, 25 mg; Pharmacia & Upjohn; October 21, 1999
• Cenestin; Treatment for symptoms associated with menopause; Duramed Pharmaceuticals; Approved July 1999
• Cenestin; Treatment for relief of vasomotor symptoms due to menopause; Duramed Pharmaceuticals; Approved March 1999
• Cleocin; Treatment for bacterial vaginosis; Pharmacia & Upjohn; Approved August 1999
• Climara; For the prevention of postmenopausal osteoporosis (loss of bone mass); Berlex Laboratories; Approved June 1999
• Doxil (doxorubicin HCl liposome injection); Treatment for ovarian cancer that is refractory to other first-line therapies; Alza; Approved June 1999
• Ellence; epirubicin hydrochloride; Pharmacia & Upjohn; Approved September 1999
• Estradiol Transdermal System; Transdermal patch system for the treatement of vulvar vaginal atrophy and vasomotor symptoms.; Wyeth-Ayerst Laboratories; Approved September 1999
• Evista; Osteoporosis treatment; Eli Lilly; Approved September 1999
• Femhrt Tablets; Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg); Parke-Davis; October 15, 1999
• Lupron Depot; Treatment for endometriosis and uterine fibroids; TAP Pharmaceuticals; Approved June 1999
• Ortho-Prefest; 17 beta estradiol/17 beta estradiol norgestimate tablets; Ortho-McNeil Pharmaceutical, R.W. Johnson; October 22, 1999
• Tequin; Tequin (Injectable and Tablet); Bristol-Myers Squibb; December, 1999

Drugs Approved in 1998

• Cleocin Vaginal Cream 2%; Treatment for bacterial vaginosis; Pharmacia & Upjohn; Approved March 1998
• Esclim; Treatment for symptoms associated to Menopause; Fournier Research; Approved August 1998
• Estratab (.3 mg ); Treatment for the prevention of osteoporosis; Solvay Pharmaceuticals; Approved March 1998
• Herceptin; Treatment for metastatic breast cancer; Genentech; Approved October 1998
• Inform HER-2/neu breast cancer test; Treatment for breast cancer prediction; Oncor; Approved January 1998
• Micardis; Treatment for Hypertension; Boehringer Ingelheim; Approved November 1998
• Mircette; Oral contraceptive; Organon; Approved April 1998
• Prempro; Treatment for hormone replacement therapy; Wyeth-Ayerst Laboratories; Approved January 1998
• PREVEN ; Emergency Contraceptive Kit; Emergency Contraceptive Pills; Gynetics; Approved September 1998
• Prometrium; Treatment for Endometrial Hyperplasia; Schering; Approved December 1998
• Prometrium; Treatment for amenorrhea (abnormal cessation of menses); Solvay Pharmaceuticals; Approved May 1998
• Xeloda; Treatment for advanced breast cancer tumors; Roche; Approved April 1998

Drugs Approved in 1997

• Alesse (100 mcg levonorgestrel/20 mcg ethinyl estradiol tablets); Treatment for the prevention of pregnancy; Wyeth-Ayerst Laboratories; Approved April 1997
• Crinone 8% (progesterone gel); Treatment for infertile women with pregestone deficiency; Wyeth-Ayerst Laboratories; Approved May 1997
• Estradiol; Generic equivalent of Estrace tablets; Duramed Pharmaceuticals; Approved December 1997
• Estradiol Tablets USP; Generic equivalent of Estrace; Barr Laboratories; Approved October 1997
• Estrostep; Treatment for oral contraception; Warner-Lambert; Approved March 1997
• Evista; Treatment for the prevention of osteoporosis; Eli Lilly; Approved December 1997
• Femara; Treatment for breast cancer; Novartis; Approved July 1997
• FEMSTAT One; Treatment for vaginal yeast infections; Roche; Approved Februrary 1997
• Flagyl ER; Treatment for bacterial vaginosis; Searle; Approved December 1997
• Floxin Tablets (ofloxacin tablets); Treatment for pelvic inflammatory disease (PID); Ortho-McNeil Pharmaceutical; Approved January 1997
• Follistim (TM) (follitropin beta for injection); Treatment for infertility; Organon; Approved September 1997
• Gonal-F (follitropin alfa for injection); Treatment for infertility; Serono Laboratories; Approved September 1997
• Miraluma test; Test for breast cancer; DuPont Pharma Radiopharmaceuticals; Approved May 1997
• Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol); Treatment for acne in women seeking contraception; Ortho Pharmaceutical; Approved January 1997
• Trivora-21 and Trivora-28; Generic equivalents of levonorgestrel and ethinyl estradiol; Watson Pharmaceuticals; Approved December 1997

Drugs Approved in 1996

• Aredia (pamidronate disodium for injection); Treatment for osteolytic bone metastases of breast cancer; Chiron Therapeutics, Ciba Pharmaceuticals; Approved August 1996
• Arimidex (anastrozole); Treatment for advanced breast cancer in postmenopausal women; Zeneca Pharmaceuticals; Approved January 1996
• Estrostep; Treatment for birth control; Parke-Davis; Approved October 1996
• FemPatch; Treatment for menopausal symptoms; Parke-Davis; Approved December 1996
• Fertinex (urofollitropin for injection, purified); Treatment for patients undergoing infertility treatments; Serono Laboratories; Approved September 1996
• Hycamtin (topotecan hydrochloride); Treatment for metastatic ovarian cancer; SmithKline Beecham; Approved May 1996
• MONISTAT 3 (miconazole nitrate); Over the counter treatment for vaginal yeast infections; Johnson & Johnson; Approved April 1996
• Seprafilm; Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery; Genzyme; Approved August 1996
• Taxotere (Docetaxel); Treatment for locally advanced or metastatic breast cancer; Rhone Poulenc Rorer; Approved May 1996
• Vivelle (estradiol transdermal system); Treatment for moderate and severe vasomotor menopausal symptoms; Ciba Pharmaceuticals; Approved March 1996

Drugs Approved in 1995

• Ethyol (amifostine); Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer; Alza, U.S. Bioscience; Approved December 8, 1995
• Femstat 3 (butoconazole nitrate 2%); Over the counter treatment for vaginal yeast infections; Procter & Gamble, Roche; Approved December 1995
• Fosamax (alendronate sodium); Treatment for osteoporosis in women after menopause and Paget's Disease of Bone; Merck; Approved on September 29, 1995
• Miacalcin (calcitonin-salmon) Nasal Spray; Treatment for post-menopausal osteoporosis; Sandoz Pharmaceuticals; Approved on August 17, 1995
• Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis; Wyeth-Ayerst Laboratories; Approved November 1995
• Self-examination breast pad; Self-examination breast pad; Inventive Products; Approved on December 22, 1995