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.

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 (aripiprazole)

Date of Approval: November 15, 2002

Abilify (aripiprazole) is a psychotropic drug indicated for the treatment of schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder and treatment of irritability associated with autistic disorder.

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

Perjeta (pertuzumab) Injection

Date of Approval: June 8, 2012

Perjeta (pertuzumab) is a humanized monoclonal antibody indicated for the combination treatment of HER2-positive metastatic breast cancer, and for the neoadjuvant treatment of breast cancer.

New Indication Approved: September 30, 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: September 27, 2013

Butrans (buprenorphine) Transdermal System

Date of Approval: June 30, 2010

Butrans (buprenorphine) is a transdermal opioid analgesic for the management of moderate to severe chronic pain in patients requiring continuous treatment for an extended period of time.

New Dosage Regimen: September 24, 2013

Stelara (ustekinumab) Injection

Date of Approval: September 25, 2009

Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

New Indication Approved: September 20, 2013

Botox Cosmetic (onabotulinumtoxinA) for Injection

Date of Approval: April 12, 2002

Botox Cosmetic (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of glabellar lines and lateral canthal lines (crow’s feet).

New Indication Approved: September 11, 2013

Abraxane (paclitaxel protein-bound) for Injectable Suspension

Date of Approval: January 7, 2005

Abraxane (paclitaxel protein-bound) is an albumin-bound form of the antineoplastic agent paclitaxel indicated for the treatment of breast cancer, non-small cell lung cancer, and pancreatic cancer.

New Indication Approved: September 6, 2013

Menveo (meningococcal conjugate vaccine)

Date of Approval: February 19, 2010

Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

Patient Population Altered: August 2, 2013

Simponi (golimumab) Injection

Date of Approval: April 24, 2009

Simponi (golimumab) is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

New Dosage Form Approved: July 18, 2013

Latuda (lurasidone) Tablets

Date of Approval: October 28, 2010

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

New Indication Approved: June 28, 2013

Isentress (raltegravir) Tablets

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.

Labeling Revision Approved: June 28, 2013

Exelon (rivastigmine) Capsules, Oral Solution and Transdermal Patch

Date of Approval: April 21, 2000

Exelon (rivastigimine) is an acetylcholinesterase inhibitor indicated for the treatment of mild to moderate Alzheimer's dementia and dementia associated with Parkinson’s disease.

New Indication Approved: June 27, 2013

Vibativ (telavancin) Injection

Date of Approval: September 11, 2009

Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI), and hospital-acquired and ventilator-associated bacterial pneumonia.

New Indication Approved: June 21, 2013

Mycamine (micafungin sodium) for Injection

Date of Approval: March 16, 2005

Mycamine (micafungin sodium) is an echinocandin antifungal agent used for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, for the treatment of esophageal candidiasis and candidemia.

Patient Population Altered: June 21, 2013

Plan B One-Step (levonorgestrel) Tablet

Date of Approval: July 10, 2009

Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure.

Patient Population Altered: June 20, 2013

Sprycel (dasatinib) Tablets

Date of Approval: June 28, 2006

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Labeling Revision Approved: June 17, 2013

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

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