New Indications and Dosage Forms for Existing Medications
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
New Indications and Dosage Forms
Date of Approval: June 20, 2003
Reyataz is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Labeling Revision Approved: November 5, 2009
Date of Approval: April 28, 2005
Byetta (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
New Indication Approved: November 2, 2009
Date of Approval: August 31, 2005
Fluarix (influenza virus vaccine, inactivated) is an influenza virus vaccine indicated for adults and children (3 years and older) for the prevention of influenza disease.
Patient Population Altered: October 19, 2009
Date of Approval: July 12, 2002
Elitek (rasburicase) is a recombinant urate-oxidase enzyme indicated for the management of plasma uric acid levels in adults and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.
Patient Population Altered: October 16, 2009
Date of Approval: June 8, 2006
Gardasil (human papillomavirus vaccine) is a recombinant vaccine indicated for the prevention of cervical, vulvar, and vaginal cancers caused by human papillomavirus (HPV) in girls and women 9 through 26 years of age. Gardasil is also approved for the prevention of genital warts caused by HPV types 6 and 11 in boys and men 9 through 26 years of age.
New Indication Approved: October 16, 2009
Date of Approval: July 29, 2009
Colcrys (colchicine) is compound derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale). Colcrys is approved for the prophylaxis and treatment of acute gout flares, and for the treatment of patients with familial Mediterranean fever.
New Indication Approved: October 16, 2009
Date of Approval: November 10, 1998
Micardis (telmisartan) is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension and for cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors.
New Indication Approved: October 16, 2009
Date of Approval: August 12, 2003
Crestor is a HMG-CoA reductase inhibitor approved as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.
Patient Population Altered: October 15, 2009
Date of Approval: May 26, 2000
Welchol (colesevelam HCl) is a bile acid sequestrant indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia, and to improve glycemic control in adults with type 2 diabetes mellitus.
Patient Population Altered: October 2, 2009
Date of Approval: December 6, 2000
Mirena (levonorgestrel) is a progestogen intrauterine delivery system indicated for intrauterine contraception for up to 5 years, and for the treatment of heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention.
New Indication Approved: October 1, 2009
Date of Approval: February 19, 2002
Zevalin is a CD20 directed, radiotherapeutic antibody indicated as part of the Zevalin therapeutic regimen for the treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's Lymphoma, including patients with rituximab refractory follicular non-Hodgkin's Lymphoma.
New Indication Approved: September 3, 2009
Date of Approval: October 15, 2008
Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.
New Formulation Approved: August 31, 2009
Date of Approval: March 29, 2001
Valcyte is a cytomegalovirus (CMV) nucleoside analogue DNA polymerase inhibitor indicated for treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and the prevention of CMV disease in high-risk adult and pediatric transplant patients.
New Dosage Form Approved: August 28, 2009
Date of Approval: May 25, 2007
Xyzal (levocetirizine) is an antihistamine for the relief of symptoms associated with allergic rhinitis and urticaria.
Patient Population Altered: August 21, 2009
Date of Approval: December 19, 2006
Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia.
New Dosage Form Approved: July 31, 2009
Date of Approval: December 19, 2006
Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia.
New Indication Approved: July 31, 2009
Date of Approval: February 26, 2004
Avastin is a recombinant humanized monoclonal IgG1 antibody for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma and renal cell carcinoma .
New Indication Approved: July 31, 2009
Date of Approval: August 3, 2004
Sculptra (injectable poly-L-lactic acid) is a dermal filler indicated for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Sculptra Aesthetic is indicated for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles in healthy patients.
New Formulation Approved: July 29, 2009
Date of Approval: November 26, 2002
Forteo [teriparatide (rDNA origin)] is recombinant human parathyroid hormone analog (1-34), [rhPTH(1-34)] indicated the treatment of osteoporosis.
New Indication Approved: July 22, 2009
Date of Approval: January 18, 2008
Tekturna HCT (aliskiren and hydrochlorothiazide) is a single-tablet combination therapy for the treatment of high blood pressure.
New Indication Approved: July 16, 2009
Date of Approval: June 7, 2000
NovoLog (insulin aspart [rDNA origin] injection) is a fast-acting synthetic insulin used to control high blood sugar in adults and children with diabetes mellitus.
Expiration Date Change Approved: July 14, 2009
Date of Approval: February 4, 2004
Alimta is an antifolate antineoplastic agent indicated for the treatment of malignant pleural mesothelioma and locally-advanced and metastatic non-small cell lung cancer (NSCLC).
New Indication Approved: July 2, 2009
Date of Approval: January 31, 2002
BioThrax (Anthrax Vaccine Adsorbed) is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons between 18 and 65 years of age at high risk of exposure.
Labeling Revision Approved: June 10, 2009
Date of Approval: June 27, 2008
Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.
Labeling Revision Approved: June 8, 2009
Date of Approval: April 16, 2007
Reclast (zoledronic acid) is a bisphosphonate indicated for the treatment for Paget's disease, postmenopausal osteoporosis and prevention of fractures.
New Dosage Regimen: June 1, 2009
Date of Approval: December 27, 1994
Lamictal (lamotrigine) is an anticonvulsant medication indicated in the treatment of epilepsy and bipolar disorder.
New Dosage Form Approved: May 29, 2009
Date of Approval: February 23, 2007
Vyvanse (lisdexamfetamine dimesylate) is an amphetamine derivative prodrug administered once-daily for the treatment of Attention Deficit Hyperactivity Disorder. Vyvanse was developed to lower abuse potential by remaining therapeutically inactive until metabolized in the body.
Labeling Revision Approved: May 22, 2009
Date of Approval: June 28, 2006
Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.
Labeling Revision Approved: May 21, 2009
Date of Approval: April 8, 1994
Prograf (tacrolimus) is a macrolide immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants.
Labeling Revision Approved: May 19, 2009
Date of Approval: December 29, 1993
Risperdal (risperidone) is an atypical antipsychotic agent indicated for the treatment of schizophrenia, acute manic or mixed episodes associated with Bipolar I Disorder and the treatment of irritability associated with autistic disorder.
New Indication Approved: May 15, 2009
Date of Approval: April 22, 2008
Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease and rheumatoid arthritis in adults.
New Indication Approved: May 13, 2009
Date of Approval: May 10, 1995
Prevacid (lansoprazole) is a proton pump inhibitor indicated for the treatment of duodenal ulcers, gastric ulcers, NSAID-induced ulcers, gastroesophageal reflux disease, erosive esophagitis and Zollinger-Ellison Syndrome.
New Dosage Form Approved: May 13, 2009
Date of Approval: August 29, 2005
Actoplus met (pioglitazone and metformin) is a combination antihyperglycemic medication used in the management of type 2 diabetes.
New Dosage Form Approved: May 12, 2009
Date of Approval: September 26, 2007
Azor is a fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Azor is indicated for the treatment of hypertension.
New Indication Approved: May 11, 2009
Date of Approval: December 27, 1994
Lamictal (lamotrigine) is an anticonvulsant medication indicated in the treatment of epilepsy and bipolar disorder.
New Dosage Form Approved: May 8, 2009
Date of Approval: February 26, 2004
Avastin is a recombinant humanized monoclonal IgG1 antibody for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma and renal cell carcinoma .
New Indication Approved: May 5, 2009
Date of Approval: May 7, 2001
Axert (almotriptan) is a 5HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine attacks in adults and adolescents.
Patient Population Altered: April 30, 2009
Date of Approval: June 15, 2005
Tygacil (tigecycline) is a glycylcycline antibacterial indicated for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia in adults.
New Indication Approved: March 20, 2009
Date of Approval: August 14, 2002
Lexapro (escitalopram oxalate) is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder and for the treatment of generalized anxiety disorder (GAD).
Patient Population Altered: March 20, 2009
Date of Approval: December 24, 2003
Symbyax (fluoxetine/olanzapine) is a selective serotonin reuptake inhibitor and atypical antipsycotic combination indicated for the acute treatment of depressive episodes associated with bipolar I disorder and treatment resistant depression.
New Indication Approved: March 19, 2009
Date of Approval: July 21, 2006
Symbicort (budesonide and formoterol) is a combination of a corticosteroid and a long-acting bronchodilator indicated for the long-term maintenance treatment of asthma and the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
New Indication Approved: February 27, 2009
Date of Approval: August 11, 1999
Temodar (temozolomide) is an imidazotetrazine derivative approved for the treatment of patients with refractory anaplastic astrocytoma and glioblastoma multiforme.
New Dosage Form Approved: February 27, 2009
Date of Approval: April 16, 2004
Apidra is a rapid-acting recombinant DNA human insulin analogue used for the control of hyperglycemia in patients with diabetes mellitus.
New Dosage Form Approved: February 24, 2009
Date of Approval: October 12, 2007
Isentress (raltegravir) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients.
Labeling Revision Approved: January 29, 2009
Date of Approval: August 16, 2007
Zingo (lidocaine hydrochloride monohydrate) is a needle-free, local anesthetic intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws.
Patient Population Altered: January 8, 2009
Date of Approval: May 10, 2001
Gleevec (imatinib mesylate) is a kinase inhibitor indicated for the treatment of chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic/ myeloproliferative diseases, mastocytosis, dermatofibrosarcoma protuberans and gastrointestinal stromal tumors.
New Indication Approved: December 19, 2008
Date of Approval: January 23, 2004
Acetadote is an injectable treatment to prevent or lessen potential liver damage resulting from acetaminophen overdose.
Labeling Revision Approved: December 12, 2008
Date of Approval: January 31, 2002
BioThrax (Anthrax Vaccine Adsorbed) is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons between 18 and 65 years of age at high risk of exposure.
New Dosage Regimen: December 11, 2008
Date of Approval: May 3, 2005
Boostrix is a combination vaccine that provides a booster immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.
Patient Population Altered: December 4, 2008
Date of Approval: December 21, 1988
Cardene (nicardipine) is a calcium channel blocker for the treatment of hypertension and angina.
New Formulation Approved: November 7, 2008
See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com
New Indications and Dosage forms Archive
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