Description of Medical Areas
About the FDA Approved Listings
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Approved Drugs for Endocrinology
Drugs Approved in 2008
Accretropin (somatropin rDNA Original); For the treatment of growth failure in pediatrics; Cangene Corp; Approved January 2008
Drugs Approved in 2007
Evamist (estradiol); For the treatment of moderate to severe vasomotor symptoms due to menopause; Vivus; Approved July 2007
Fenofibrate; For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia; LifeCycle Pharma; Approved August 2007
Somatuline Depot (lanreotide acetate); For the treatment of acromegaly; Beaufour Ipsen; 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
Byetta (exenatide); For the adjunctive treatment of Type 2 diabetes mellitus; Amylin/Eli Lilly; Approved April, 2005
Increlex (mecasermin); For the treatment of growth failure due to Primary IGFD; Tercica; Approved August 2005
Symlin (pramlintide); For the treatment of type I and type II diabetes; Amylin Pharmaceuticals; Approved March 2005
Drugs Approved in 2004
No approvals recorded for Endocrinology in 2004.
Drugs Approved in 2003
Aldurazyme (laronidase); For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65; Genzyme; Approved May 2003
Fabrazyme (agalsidase beta); For the treatment of Fabry disease in adult patients; Genzyme; Approved April 2003
Somavert (pegvisomant); Injectable formulation for the treatment of acromegaly; Pharmacia; Approved March 2003
Drugs Approved in 2002
Avandamet (rosiglitazone maleate and metformin HCl); For improvement of glycemic control in type 2 diabetes patients; GlaxoSmithKline; Approved October 2002
Benicar; Oral tablet for the treatment of hypertension; Sankyo Pharma; 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
Levo-T (levothyroxine sodium); Indicated for the treatment of hypothyroidism and the suppression of thyroid stimulating hormone; Mova Pharmaceutical; Approved March 2002
Metaglip (glipizide/metformin HCl); Oral tablets for the treatment of type 2 diabetes.; Bristol-Myers Squibb; Approved October 2002
Novothyrox (levothyroxine sodium); For the treatment of hypothyroidism and suppression of thyroid-stimulating hormone; Genpharm; Approved May 2002
Synthroid (levothyroxine sodium); For replacement or supplemental therapy for hypothyroidism and pituitary thyroid stimulating hormone suppression; Abbott Laboratories; Approved July 2002
Testim; External cream for the treatment of male hormone deficiency.; Auxilium Pharmaceuticals; Approved October 2002
Drugs Approved in 2001
Campath; Injectable treatment of B-cell chronic lymphocytic leukemia; Berlex Laboratories; Approved May 2001
Femara (letrozole) Tablets; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer; Novartis; Approved January 2001
Genotropin (somatropin); For the treatment of growth failure in children who were born small for gestational age (SGA); Pharmacia; Approved July 2001
Gleevec; Oral therapy for the treatment of chronic myeloid leukemia; Novartis; Approved May 2001
Levoxyl; Oral therapy for the treatment of hypothyroidism and suppression of thyroid-stimulating hormone (TSH); Jones Pharma; Approved May 2001
Natrecor (nesiritide); For the treatment of patients with acutely decompensated congestive heart failure; Scios; Approved August 2001
Novolog Mix 70/30; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2 diabetes; Novo Nordisk; Approved November 2001
Prozac Weekly (fluoxetine HCl); For the treatment of depression; Eli Lilly; Approved February 2001
Remeron SolTab (mirtazapine); Orally disintegrating tablet for the treatment of depression; Organon; Approved January 2001
Remicade (infliximab); For inhibiting the progression of structural damage in patients with rheumatoid arthritis; Centocor; Approved January 2001
Trelstar LA; Intramuscular injection for the treatment of advanced stage prostate cancer; Debiopharm; Approved June 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
AndroGel testosterone gel; For testosterone replacement therapy in males with testosterone deficiency; Unimed Pharmaceuticals; Approved February 2000
Atacand HCT; For the treatment of hypertension; AstraZeneca; Approved September 2000
Cetrotide; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation; Asta Medica; Approved August 2000
Diltiazem HCL, Extended-Release Capsules; For the reduction of high blood pressure; Biovail Laboratories; Approved January 2000
Hectorol (Doxercalciferol) Injection; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis; Bone Care International; Approved April 2000
Lantus (insulin glargine [rDNA origin] injection); For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia; Aventis Pharmaceuticals; Approved April 2000
Lescol XL (fluvastatin sodium) tablet, extended release; For the use as an adjunct to diet to reduce elevated total cholesterol; Novartis; Approved October 2000
Micardis (hydrochlorothiazide; telmisartan) Tablet; For the treatment of hypertension; Boehringer Ingelheim; Approved November 2000
Mirena (levonorgestrel-releasing intrauterine system); Hormone-releasing system for intrauterine contraception; Berlex Laboratories; Approved December 2000
NovoLog (insulin aspart); An insulin analogue for the treatment of diabetes mellitus.; Novo Nordisk; Approved June 2000
Ovidrel (gonadotropin, chorionic human recombinant); For the induction of final follicular maturation and early luteinization in infertile women; Serono Laboratories; Approved September 2000
Trelstar Depot (Injectable Triptorelin Pamoate); For the palliative treatment of advanced prostate cancer; Debio Rechereche Pharmaceutique, Target Research Associates; Approved June 2000
Viadur (leuprolide acetate implant); For pain relief in men with advanced prostate cancer; Alza; Approved March 2000
Vivelle; For the prevention of postmenopausal osteoporosis; Novartis; Approved August 2000
Drugs Approved in 1999
ACTOS; Treatment for type II diabetes; Takeda; Approved July 1999
Aggrenox; Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke; Boehringer Ingelheim; Approved November 1999
Aromasin Tablets; Exemestane Tablets, 25 mg; Pharmacia & Upjohn; October 21, 1999
Avandia (rosiglitazone maleate); Treatment for type II diabetes mellitus; SmithKline Beecham; Approved June 1999
Cernevit; For the treatment of vitamin deficiency; Baxter Healthcare; Approved April 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
Ethyol (amifostine); Treatment for xerostomia (dry mouth) due to radiation; U.S. Bioscience, Alza; Approved June 1999
Evista; Osteoporosis treatment; Eli Lilly; Approved September 1999
Femhrt Tablets; Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg); Parke-Davis; October 15, 1999
Ortho-Prefest; 17 beta estradiol/17 beta estradiol norgestimate tablets; Ortho-McNeil Pharmaceutical, R.W. Johnson; October 22, 1999
Drugs Approved in 1998
Actonel; Treatment for Paget's Disease; Procter & Gamble, Hoechst Marion Roussel; Approved April 1998
Arava; Treatment for Rheumatoid Arthritis; Hoechst Marion Roussel; Approved September 1998
Atacand; Treatment for hypertension; Astra Merck; Approved June 1998
Atacand (R) (candesartan cilexetil); Treatment for hypertension; Astra Merck; Approved June 1998
Celexa; Treatment for depression; Forest Laboratories; Approved July 1998
CellCept; Treatment for the prevention of organ rejection inpatients undergoing heart transplants; Roche; Approved February 1998
Clomipramine hydrochloride; Generic equivalent of Anafranil; Mylan Laboratories; Approved April 1998
Diovan HCT; Treatment for hypertension; Novartis; 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
Glucagon; Treatment for severe Hypoglycemia; Eli Lilly; Approved September 1998
Glucagon; Treatment for severe hypoglycemia associated with diabetes.; Eli Lilly; Approved October 1998
Glyburide Tablets; Treatment for Diabetes Mellitus (Type II); Mylan Laboratories; Approved July 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
Marplan Tablets; Treatment of Depression; Roche; Approved August 1998
Mircette; Oral contraceptive; Organon; Approved April 1998
Prempro; Treatment for hormone replacement therapy; Wyeth-Ayerst Laboratories; Approved January 1998
Prometrium; Treatment for Endometrial Hyperplasia; Schering; Approved December 1998
Proscar; Treatment for complication relating to benign prostatic hyperplasia (BPH); Merck; Approved April 1998
Simulect; Treatment for acute organ transplant rejection; Novartis; Approved May 1998
Xeloda; Treatment for advanced breast cancer tumors; Roche; Approved April 1998
Zemplar; Treatment of secondary hyperparathyroidism associated with chronic renal failure; Abbott Laboratories; Approved April 1998
Drugs Approved in 1997
Baycol (cerivastatin sodium); Treatment for high cholesterol; Bayer; Approved June 1997; withdrawn 8/8/01
Captopril and hydrochlorotiazide; Treatment for hypertension; Mylan Laboratories; Approved May 1997
Captopril and hydrochlorotiazide; Generic equivalent of Capozide; Mylan Laboratories; Approved (tentatively) May 20, 1997
Corlopam; Treatment for severe high blood pressure; Neurex; Approved September 1997
Crinone 8% (progesterone gel); Treatment for infertile women with pregestone deficiency; Wyeth-Ayerst Laboratories; Approved May 1997
Diovan; Oral capsules and tablets for the treatment of hypertension; Novartis; Approved January 1997 (capsules); July 2001 (tablets)
Diovan (valsartan); Treatment for hypertension; Ciba Pharmaceuticals; Approved January 1997
Dostinex Tablets (cabergoline tablets); Treatment of hyperprolactinemic disorders; Pharmacia & Upjohn; Approved January 1997
DynaCirc CR; Treatment for hypertension; Novartis; Approved February 1997
Effexor (R) XR (venlafaxin HCI); Treatment of depression; Wyeth-Ayerst Laboratories; Approved October 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
Etodolac Tablets USP, 400mg; Generic equivalent of Lodine; Royce Laboratories; Approved April 1997
Evista; Treatment for the prevention of osteoporosis; Eli Lilly; Approved December 1997
Femara; Treatment for breast cancer; Novartis; Approved July 1997
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