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: October 16, 1978
Premarin Vaginal Cream is a vaginal estrogen therapy indicated for the treatment of atrophic vaginitis, kraurosis vulvae and the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.
New Indication Approved: November 7, 2008
Date of Approval: May 26, 2005
Focalin XR is a once-daily extended-release form of Focalin indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.
Labeling Revision Approved: October 17, 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
Date of Approval: January 27, 2006
Ranexa is an antianginal and anti-ischemic agent indicated for the treatment of chronic angina.
New Indication Approved: November 5, 2008
Date of Approval: March 20, 2008
Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent non-Hodgkin's lymphoma.
New Indication Approved: October 31, 2008
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.
Patient Population Altered: October 24, 2008
Date of Approval: December 29, 2005
Vaprisol (conivaptan hydrochloride injection) is an arginine vasopressin antagonist for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients.
New Formulation Approved: October 8, 2008
Date of Approval: June 23, 2006
Prezista is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.
Patient Population Altered: October 21, 2008
Date of Approval: September 26, 1997
Seroquel (quetiapine) is a psychotropic agent used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder.
New Indication Approved: October 8, 2008
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 Dosage Regimen: October 10, 2008
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.
Patient Population Altered: September 30, 2008
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: September 26, 2008
Date of Approval: October 29, 2004
ProAir HFA (albuterol sulfate) inhalation aerosol is a beta2-adrenergic agonist indicated for treatment or prevention of bronchospasm.
Patient Population Altered: September 16, 2008
Date of Approval: July 11, 1991
Nasacort (triamcinolone acetonide) is an intranasal corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.
Patient Population Altered: September 19, 2008
Date of Approval: August 27, 2003
Gamunex (immune globulin intravenous (human)) is indicated for the treatment of primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy (CIDP).
New Indication Approved: September 12, 2008
Date of Approval: November 30, 1999
Keppra is an antiepileptic drug used to treat partial onset seizures in people with epilepsy. It is also used to treat myoclonic seizures and tonic-clonic seizures.
New Dosage Form Approved: September 12, 2008
Date of Approval: June 8, 2006
Gardasil is a recombinant vaccine indicated for the prevention of cervical, vulvar, and vaginal cancers caused by human papillomavirus in girls and women 9 through 26 years of age.
New Indication Approved: September 12, 2008
Date of Approval: May 30, 2006
Omnitrope is a recombinant human growth hormone indicated for treatment of children with growth failure due to growth hormone deficiency GHD and treatment of adults with either adult onset or childhood onset GHD.
New Formulation Approved: August 25, 2008
Date of Approval: November 1, 2001
Novolog Mix (insulin aspart and insulin aspart protamine) is an insulin combination used to treat type 1 (insulin-dependent) diabetes in adults.
New Formulation Approved: August 26, 2008
Date of Approval: July 25, 2003
Aloxi is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with chemotherapy.
New Dosage Form Approved: August 22, 2008
Date of Approval: May 19, 2004
Vidaza (azacitidine) is an antineoplastic agent for the treatment of patients with myelodysplastic syndromes.
New Indication Approved: August 20, 2008
Date of Approval: October 26, 2001
Viread (tenofovir disoproxil fumarate) is a nucleoside reverse transcriptase inhibitor (NRTI) for the treatment of HIV infection and chronic hepatitis B in adults.
New Indication Approved: August 11, 2008
Date of Approval: June 20, 2007
Exforge is a single-tablet combination of an angiotensin receptor blocker (valsartan) and a calcium channel blocker (amlodipine) taken once-daily for the treatment of hypertension.
New Indication Approved: July 23, 2008
Date of Approval: December 21, 1988
Cardene (nicardipine) is a calcium channel blocker for the treatment of hypertension and angina.
New Formulation Approved: July 31, 2008
Date of Approval: August 19, 1999
Aciphex (rabeprazole) is a proton-pump inhibitor indicated for the treatment of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid.
Patient Population Altered: June 30, 2008
Date of Approval: July 27, 2004
Metvixia is a non-invasive treatment which combines the local application of cream and illumination with a proprietary red light source (CureLight/Aktilite) to activate the drug for the photodynamic treatment of sun-induced pre-cancerous skin lesions (actinic keratosis).
New Formulation Approved: June 26, 2008
Date of Approval: August 1, 2000
Concerta (methylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.
Patient Population Altered: June 27, 2008
Date of Approval: June 22, 2005
Aptivus is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection.
New Dosage Form Approved: June 23, 2008
Date of Approval: May 13, 2003
Velcade is an antineoplastic agent indicated for the treatment of multiple myeloma.
New Indication Approved: June 20, 2008
Date of Approval: November 20, 2001
Avodart (dutasteride) is a 5á-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
New Indication Approved: June 19, 2008
Date of Approval: August 3, 2004
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta is indicated for the treatment of major depressive disorder, neuropathic pain associated with diabetic peripheral neuropathy, generalized anxiety disorder and fibromyalgia.
New Indication Approved: June 13, 2008
Date of Approval: September 19, 1997
Requip (ropinirole) is a non-ergoline dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
New Dosage Form Approved: July 1, 2008
Date of Approval: April 16, 2007
Reclast is a bisphosphonate indicated for the treatment for Paget's disease, postmenopausal osteoporosis and prevention of fractures.
New Indication Approved: June 3, 2008
Date of Approval: September 26, 1997
Seroquel (quetiapine) is a psychotropic agent used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder.
New Indication Approved: May 13, 2008
Date of Approval: January 9, 2006
Taclonex is a topical ointment containing a combination of calcipotriene and betamethasone for the treatment of psoriasis vulgaris in adults.
New Dosage Form Approved: May 9, 2008
- FDA Approves Taclonex Scalp - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
Date of Approval: November 15, 2002
Abilify (aripiprazole) is a psychotropic drug indicated for the treatment of schizophrenia, bipolar disorder and adjunctive treatment of major depressive disorder.
New Indication Approved: May 6, 2008
Date of Approval: November 15, 2002
Abilify (aripiprazole) is a psychotropic drug indicated for the treatment of schizophrenia, bipolar disorder and adjunctive treatment of major depressive disorder.
New Indication Approved: May 6, 2008
Date of Approval: November 26, 2002
Strattera is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
New Indication Approved: May 7, 2008
Date of Approval: February 23, 2007
Vyvanse 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.
Patient Population Altered: April 23, 2008
Date of Approval: July 25, 2003
Aloxi is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with chemotherapy.
New Indication Approved: February 29, 2008
Date of Approval: November 15, 2002
Abilify (aripiprazole) is a psychotropic drug indicated for the treatment of schizophrenia, bipolar disorder and adjunctive treatment of major depressive disorder.
Patient Population Altered: February 27, 2008
Date of Approval: February 20, 2001
Nexium (esomeprazole magnesium) is a proton pump inhibitor indicated for the healing and maintenance of healing of erosive esophagitis, treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for use in combination with amoxicillin and clarithromycin for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, prevention of NSAID-induced gastric ulcers and Zollinger-Ellison Syndrome.
New Dosage Form Approved: February 27, 2008
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 and HER2-negative breast cancer.
New Indication Approved: February 22, 2008
Date of Approval: December 31, 2002
Humira is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis and juvenile idiopathic arthritis.
New Indication Approved: February 21, 2008
- Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
Date of Approval: May 25, 2007
Xyzal is an antihistamine for the relief of symptoms associated with allergic rhinitis and urticaria.
New Dosage Form Approved: January 28, 2008
Date of Approval: March 30, 2005
Asmanex Twisthaler (mometasone furoate) is an inhaled corticosteroid for the treatment of asthma.
Patient Population Altered: February 4, 2008
Date of Approval: December 31, 2002
Humira is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis and juvenile idiopathic arthritis.
New Indication Approved: January 18, 2008
Date of Approval: November 23, 2004
Tysabri (natalizumab) is a recombinant humanized IgG4κ monoclonal antibody for the treatment of multiple sclerosis and Crohn's disease.
New Indication Approved: January 14, 2008
Date of Approval: November 21, 2003
Cialis is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) indicated for the treatment of erectile dysfunction. Although there are other drugs on the market for this indication, this drug is different in that it may work up to 36 hours after dosing.
New Dosage Regimen: January 7, 2008
Date of Approval: February 23, 2007
Vyvanse 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.
New Dosage Form Approved: December 10, 2007
See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com
