Listing of Newly Approved Drug Therapies (2007)

Description of Medical Areas

About the FDA Approved Listings

Drugs Approved by the FDA (2007)

Approval Year:

2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 | 1995 | All Years

Cardiology/Vascular Diseases
Dental/Maxillofacial Surgery
Dermatology/Plastic Surgery
Endocrinology
Gastroenterology
Hematology
Immunology/Infectious Diseases
Musculoskeletal
Nephrology/Urology
Neurology

Obstetrics/Gynecology
Oncology
Ophthalmology
Otolaryngology
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma/Emergency Medicine

The following drugs have been approved this year by the Food and Drug Administration.

Cardiology/Vascular Diseases

Azor (amlodipine besylate; olmesartan medoxomil); For the treatment of hypertension; Daiichi Sankyo; Approved September 2007
Fenofibrate; For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia; LifeCycle Pharma; Approved August 2007
Letairis (ambrisentan); For the treatment of pulmonary arterial hypertension; Gilead; Approved June 2007
Soliris (eculizumab); For the treatment of paroxysmal nocturnal hemoglobinuria; Alexion Pharm; Approved March 2007
Tekturna (aliskiren); For the treatment of hypertension; Novartis Pharms; Approved March 2007

Dental/Maxillofacial Surgery

No approvals recorded to date in this area.

Dermatology/Plastic Surgery

Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
Extina (ketoconazole); For the treatment of seborrheic dermatitis; Stiefel; Approved June 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

Endocrinology

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
Supprelin LA (histrelin acetate); For the treatment of central precocious puberty; Indevis Pharms; Approved May 2007

Gastroenterology

No approvals recorded to date in this area.

Hematology

Kuvan (sapropterin dihydrochloride); For the treatment of hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria; Biomarin; Approved December 2007
Mircera (methoxy polyethylene glycol-epoetin beta); For the treatment of anemia associated with chronic renal failure; Hoffman La-Roche; Approved November 2007
Soliris (eculizumab); For the treatment of paroxysmal nocturnal hemoglobinuria; Alexion Pharm; Approved March 2007

Immunology/Infectious Diseases

Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
AzaSite (azithromycin); For the treatment of bacterial conjunctivitis; InSite Vision; Approved April 2007
Doribax (doripenem); For the treatment of intra-abdominal infections and urinary tract infections; Johnson & Johnson; Approved October 2007
Extina (ketoconazole); For the treatment of seborrheic dermatitis; Stiefel; Approved June 2007
Isentress (raltegravir); For the treatment of HIV-1; Merck; Approved October 2007
Selzentry (maraviroc); For the treatment of CCR5-tropic HIV-1; Pfizer; Approved August 2007
Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

Musculoskeletal

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
Reclast (zoledronic acid); For the treatment of Paget's disease; Novartis Pharms; Approved April 2007
Somatuline Depot (lanreotide acetate); For the treatment of acromegaly; Beaufour Ipsen; Approved August 2007

Nephrology/Urology

Doribax (doripenem); For the treatment of intra-abdominal infections and urinary tract infections; Johnson & Johnson; Approved October 2007
Mircera (methoxy polyethylene glycol-epoetin beta); For the treatment of anemia associated with chronic renal failure; Hoffman La-Roche; Approved November 2007
Torisel (temsirolimus); For the treatment of renal cell carcinoma; Wyeth Pharms; Approved May 2007

Neurology

Exelon (rivastigmine tartrate); For the treatment of Alzheimer's and Parkinson's disease-related dementia; Novartis Pharms; Approved July 2007
Neupro (rotigotine); For the treatment of Parkinson's disease; Schwarz; Approved May 2007
Nuvigil (armodafinil); For the treatment of excessive sleepiness; Cephalon; Approved June 2007
Vyvanse (Lisdexamfetamine Dimesylate); For the treatment of Attention-Deficit/Hyperactivity Disorder; New River; Approved February 2007

Obstetrics/Gynecology

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

Oncology

Evista (raloxifene hydrochloride); For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women; Eli Lilly; Approved September 2007
Hycamtin (topotecan); For the treatment of small cell lung cancer; GlaxoSmithKline; Approved October 2007
Ixempra (ixabepilone); For the treatment of breast cancer; Bristol Myers Squibb; Approved October 2007
Tasigna (nilotinib hydrochloride monohydrate); For the treatment of chronic myelogenous leukemia; Novartis; Approved October 2007
Torisel (temsirolimus); For the treatment of renal cell carcinoma; Wyeth Pharms; Approved May 2007
Tykerb (lapatinib); For the treatment of breast cancer; GlaxoSmithKline; Approved March 2007

Ophthalmology

AzaSite (azithromycin); For the treatment of bacterial conjunctivitis; InSite Vision; Approved April 2007

Otolaryngology

Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

Pediatrics/Neonatology

Altabax (retapamulin); For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes; Glaxo; Approved April 2007
Supprelin LA (histrelin acetate); For the treatment of central precocious puberty; Indevis Pharms; Approved May 2007
Veramyst (fluticasone furoate); For the treatment of seasonal and perennial allergic rhinitis; GlaxoSmithKline; Approved April 2007
Vyvanse (Lisdexamfetamine Dimesylate); For the treatment of Attention-Deficit/Hyperactivity Disorder; New River; Approved February 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007
Zingo (lidocaine hydrochloride monohydrate); For local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3 to 18 years of age; Anesiva; Approved August 2007

Pharmacology/Toxicology

No approvals recorded to date in this area.

Psychiatry/Psychology

Vyvanse (Lisdexamfetamine Dimesylate); For the treatment of Attention-Deficit/Hyperactivity Disorder; New River; Approved February 2007

Pulmonary/Respiratory Diseases

Letairis (ambrisentan); For the treatment of pulmonary arterial hypertension; Gilead; Approved June 2007
Xyzal (levocetirizine dihydrochloride); For the treatment of seasonal and perennial allergic rhinitis and urticaria; UCB Inc.; Approved May 2007

Rheumatology

No approvals recorded to date in this area.

Trauma/Emergency Medicine

No approvals recorded to date in this area.

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Drug listings last updated: July 3, 2008 at 2:32:27 PM

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