Pill Identifier App

New Indications & Dosage Forms for Existing Drugs

Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.

QNASL (beclomethasone dipropionate) Nasal Aerosol

Date of Approval: March 23, 2012

QNASL (beclomethasone dipropionate) is an intranasal corticosteroid non-aqueous "dry" spray formulation for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).

New Formulation Approved: December 19, 2014

Erwinaze (asparaginase Erwinia chrysanthemi) Injection

Date of Approval: November 18, 2011

Erwinaze (asparaginase Erwinia chrysanthemi) is an antineoplastic agent used to treat patients with acute lymphoblastic leukemia (ALL) who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs.

New Dosage Regimen: December 19, 2014

Somatuline Depot (lanreotide acetate) Injection

Date of Approval: August 30, 2007

Somatuline Depot (lanreotide) is a long acting somatostatin analogue indicated for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors.

New Indication Approved: December 16, 2014

Cyramza (ramucirumab) Injection

Date of Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for the treatment of advanced gastric cancer and non-small cell lung cancer.

New Indication Approved: December 12, 2014

Fluzone (influenza virus vaccine, inactivated) Suspension for Intramuscular Injection

Date of Approval: September 4, 2002

Fluzone is an inactivated influenza virus vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B.

New Formulation Approved: December 12, 2014

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

New Dosage Form Approved: December 11, 2014

Xgeva (denosumab) Injection

Date of Approval: November 18, 2010

Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, and for the treatment of giant cell tumor of the bone.

New Indication Approved: December 5, 2014

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension

Date of Approval: February 28, 2013

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia.

Labeling Revision Approved: December 5, 2014

Jakafi (ruxolitinib) Tablets

Date of Approval: November 16, 2011

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of patients with myelofibrosis and polycythemia vera.

New Indication Approved: December 4, 2014

Priftin (rifapentine) Tablets

Date of Approval: June 22, 1998

Priftin (rifapentine) is a rifamycin antimycobacterial indicated for the treatment of pulmonary tuberculosis.

New Indication Approved: November 25, 2014

Auryxia (ferric citrate) Tablets

Date of Approval: September 5, 2014

Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Labeling Revision Approved: November 17, 2014

Avastin (bevacizumab) Injection

Date of Approval: February 26, 2004

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma, renal cell carcinoma, and cervical cancer.

New Indication Approved: November 14, 2014

Invega (paliperidone)

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 treatment of schizophrenia and schizoaffective disorder.

New Indication Approved: November 13, 2014

Cyramza (ramucirumab) Injection

Date of Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for the treatment of advanced gastric cancer and non-small cell lung cancer.

Labeling Revision Approved: November 5, 2014

Olysio (simeprevir) Capsules

Date of Approval: November 22, 2013

Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.

Labeling Revision Approved: November 5, 2014

Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules

Date of Approval: August 13, 2009

Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain.

Labeling Revision Approved: October 17, 2014

Uceris (budesonide)

Date of Approval: January 14, 2013

Uceris (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

New Dosage Form Approved: October 8, 2014

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension

Date of Approval: February 28, 2013

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia.

New Dosage Form Approved: September 29, 2014

Ozurdex (dexamethasone) Intravitreal Implant

Date of Approval: June 17, 2009

Ozurdex (dexamethasone intravitreal implant) is a sustained-release, corticosteroid implant for the treatment of macular edema, non-infectious uveitis, and diabetic macular edema.

New Indication Approved: September 26, 2014

Spiriva Respimat (tiotropium bromide) Inhalation Spray

Date of Approval: September 24, 2014

Spiriva Respimat (tiotropium bromide) is an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

New Formulation Approved: September 25, 2014

Otezla (apremilast) Tablets

Date of Approval: March 21, 2014

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis and plaque psoriasis.

New Indication Approved: September 23, 2014

Minivelle (estradiol) Transdermal System

Date of Approval: October 29, 2012

Minivelle (estradiol) is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, and for the prevention of postmenopausal osteoporosis.

New Indication Approved: September 23, 2014

Humira (adalimumab) Injection

Date of Approval: December 31, 2002

Humira (adalimumab) 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, juvenile idiopathic arthritis, and ulcerative colitis.

Patient Population Altered: September 23, 2014

Promacta (eltrombopag) Tablets

Date of Approval: November 20, 2008

Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura.

New Indication Approved: August 26, 2014

Zorvolex (diclofenac) Capsules

Date of Approval: October 18, 2013

Zorvolex (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain, and for the management of osteoarthritis pain.

New Indication Approved: August 22, 2014

Eliquis (apixaban) Tablets

Date of Approval: December 28, 2012

Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery.

New Indication Approved: August 21, 2014

Avastin (bevacizumab) Injection

Date of Approval: February 26, 2004

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma, renal cell carcinoma, and cervical cancer.

New Indication Approved: August 14, 2014

Lumizyme (alglucosidase alfa)

Date of Approval: May 24, 2010

Lumizyme (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for patients with Pompe disease.

Patient Population Altered: August 1, 2014

Eylea (aflibercept) Injection

Date of Approval: November 18, 2011

Eylea (aflibercept) is a VEGF inhibitor for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME).

New Indication Approved: July 29, 2014

Imbruvica (ibrutinib) Capsules

Date of Approval: November 13, 2013

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.

New Indication Approved: July 28, 2014

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Date of Approval: March 13, 2013

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated for lymphatic mapping in patients with breast cancer or melanoma, and for guiding sentinel lymph node biopsy in patients with squamous cell carcinoma of the oral cavity.

New Indication Approved: June 13, 2014

Pradaxa (dabigatran etexilate) Capsules

Date of Approval: October 19, 2010

Pradaxa (dabigatran etexilate) is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; and for the treatment and reduction of risk of deep vein thrombosis and pulmonary embolism.

New Indication Approved: April 7, 2014

Kalbitor (ecallantide) Injection

Date of Approval: December 1, 2009

Kalbitor (ecallantide) is plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

New Dosage Form Approved: April 3, 2014

Topamax (topiramate)

Date of Approval: December 24, 1996

Topamax (topiramate) is an antiepileptic agent indicated for the treatment of epilepsy, and the prevention of migraine headache.

Patient Population Altered: March 28, 2014

Nexium (esomeprazole)

Date of Approval: February 20, 2001

Nexium (esomeprazole) 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 Formulation Approved: March 28, 2014

Xolair (omalizumab) Subcutaneous Injection

Date of Approval: June 20, 2003

Xolair (omalizumab) is a monoclonal antibody indicated for the treatment of patients with moderate to severe persistent asthma, and chronic idiopathic urticaria.

New Indication Approved: March 21, 2014

Noxafil (posaconazole)

Date of Approval: September 15, 2006

Noxafil is a triazole antifungal agent indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

New Dosage Form Approved: March 13, 2014

Eliquis (apixaban) Tablets

Date of Approval: December 28, 2012

Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery.

New Indication Approved: March 13, 2014

Bydureon (exenatide) Extended-Release Injectable Suspension

Date of Approval: January 27, 2012

Bydureon (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.

New Dosage Form Approved: March 3, 2014

Imbruvica (ibrutinib) Capsules

Date of Approval: November 13, 2013

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.

New Indication Approved: February 12, 2014

Copaxone (glatiramer acetate) Injection

Date of Approval: December 20, 1996

Copaxone (glatiramer acetate) is an immunomodulator drug indicated for the treatment of relapsing forms of multiple sclerosis.

New Dosage Form Approved: January 28, 2014

Retin-A Micro (tretinoin) Topical Gel

Date of Approval: February 7, 1997

Retin-A Micro (tretinoin) Gel microsphere is a retinoid indicated for topical treatment of acne vulgaris.

New Dosage Form Approved: January 28, 2014

Mekinist (trametinib) Tablets

Date of Approval: May 29, 2013

Mekinist (trametinib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

New Indication Approved: January 9, 2014

Xiaflex (collagenase clostridium histolyticum)

Date of Approval: February 3, 2010

Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.

New Indication Approved: December 6, 2013

Noxafil (posaconazole)

Date of Approval: September 15, 2006

Noxafil is a triazole antifungal agent indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

New Dosage Form Approved: November 25, 2013

Nexavar (sorafenib) Tablets

Date of Approval: December 20, 2005

Nexavar (sorafenib) is an oral multi-kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma, liver cancer, and thyroid cancer.

New Indication Approved: November 22, 2013

Influenza Virus Vaccine, H5N1 () Injection

Date of Approval: April 17, 2007

Influenza Virus Vaccine, H5N1 is a vaccine indicated for the prevention of H5N1 influenza virus, commonly referred to as avian influenza or "bird flu."

New Formulation Approved: November 22, 2013

Actemra (tocilizumab) Injection

Date of Approval: January 8, 2010

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults, and the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.

New Formulation Approved: October 21, 2013

Cimzia (certolizumab pegol) Injection

Date of Approval: April 22, 2008

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis and psoriatic arthritis in adults.

New Indication Approved: October 17, 2013

Nasacort (triamcinolone acetonide) Nasal Aerosol

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.

New Formulation Approved: October 11, 2013

See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com

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