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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.

ProAir RespiClick (albuterol sulfate) Inhalation Powder

Date of Approval: March 31, 2015

ProAir RespiClick (albuterol sulfate) is a breath-actuated, dry-powder, short-acting beta-agonist (SABA) inhaler for the relief of acute asthma symptoms.

Patient Population Altered: April 29, 2016

See approval history for ProAir RespiClick

Gilotrif (afatinib) Tablets

Date of Approval: July 12, 2013

Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

New Indication Approved: April 15, 2016

See approval history for Gilotrif

Xalkori (crizotinib) Capsules

Date of Approval: August 26, 2011

Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive.

New Indication Approved: March 11, 2016

See approval history for Xalkori

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, chronic lymphocytic leukemia, and Waldenström’s macroglobulinemia.

New Indication Approved: March 4, 2016

See approval history for Imbruvica

Afinitor (everolimus) Tablets

Date of Approval: March 30, 2009

Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced HR+, HER2- breast cancer; progressive neuroendocrine tumors of pancreatic origin (PNET); progressive neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin; advanced renal cell carcinoma; and subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis.

New Indication Approved: February 26, 2016

See approval history for Afinitor

Gazyva (obinutuzumab) Injection

Date of Approval: November 1, 2013

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with previously untreated chronic lymphocytic leukemia and follicular lymphoma.

New Indication Approved: February 26, 2016

See approval history for Gazyva

Xeljanz (tofacitinib) Tablets

Date of Approval: November 6, 2012

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

New Dosage Form Approved: February 24, 2016

See approval history for Xeljanz

Aczone (dapsone) Gel

Date of Approval: July 7, 2005

Aczone (dapsone) is a sulfone indicated for the topical treatment of acne vulgaris.

New Formulation Approved: February 24, 2016

See approval history for Aczone

Ibrance (palbociclib) Capsules

Date of Approval: February 3, 2015

Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor for the combination treatment of ER+, HER2- metastatic breast cancer.

Labeling Revision Approved: February 19, 2016

See approval history for Ibrance

Harvoni (ledipasvir and sofosbuvir) Tablets

Date of Approval: October 10, 2014

Harvoni (ledipasvir and sofosbuvir) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection.

New Indication Approved: February 12, 2016

See approval history for Harvoni

Daklinza (daclatasvir) Tablets

Date of Approval: July 24, 2015

Daklinza (daclatasvir) is an NS5A inhibitor indicated for use in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.

New Indication Approved: February 5, 2016

See approval history for Daklinza

Halaven (eribulin mesylate) Injection

Date of Approval: November 15, 2010

Halaven (eribulin mesylate) is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer, and liposarcoma.

New Indication Approved: January 28, 2016

See approval history for Halaven

Opdivo (nivolumab) Injection

Date of Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma and non-small cell lung cancer.

New Indication Approved: January 23, 2016

See approval history for Opdivo

Kyprolis (carfilzomib) Injection

Date of Approval: July 20, 2012

Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma.

New Indication Approved: January 21, 2016

See approval history for Kyprolis

Dalvance (dalbavancin) Injection

Date of Approval: May 23, 2014

Dalvance (dalbavancin) is a second generation lipoglycopeptide antibiotic for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

New Dosage Regimen: January 21, 2016

See approval history for Dalvance

Botox (onabotulinumtoxinA) Injection

Date of Approval: December 9, 1991

Botox (onabotulinumtoxinA) is a neurotoxin complex indicated for the treatment of cervical dystonia, severe primary axillary hyperhidrosis (underam sweating), upper limb spasticity, lower limb spasticity, prevention of chronic migraine, urinary incontinence in people with neurologic conditions, and overactive bladder.

New Indication Approved: January 21, 2016

Cosentyx (secukinumab) Injection

Date of Approval: January 21, 2015

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.

New Indication Approved: January 15, 2016

See approval history for Cosentyx

Arzerra (ofatumumab) Injection

Date of Approval: October 26, 2009

Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

Labeling Revision Approved: January 15, 2016

See approval history for Arzerra

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection

Date of Approval: August 19, 2009

Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children aged six weeks through four years of age (prior to fifth birthday).

Patient Population Altered: January 14, 2016

See approval history for Hiberix

Humulin R (insulin human) Injection

Date of Approval: October 28, 1982

Humulin R (insulin human) is a regular short-acting insulin indicated to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus.

New Dosage Form Approved: December 29, 2015

Xeomin (incobotulinumtoxinA) Injection

Date of Approval: July 30, 2010

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of adults with cervical dystonia, blepharospasm, glabellar lines, and upper limb spasticity.

New Indication Approved: December 22, 2015

See approval history for Xeomin

Keytruda (pembrolizumab) for Injection

Date of Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma and metastatic non-small cell lung cancer.

New Indication Approved: December 18, 2015

See approval history for Keytruda

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) Injection

Date of Approval: December 10, 2014

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.

Patient Population Altered: December 15, 2015

See approval history for Gardasil 9

Opdivo (nivolumab) Injection

Date of Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma and non-small cell lung cancer.

New Indication Approved: November 23, 2015

See approval history for Opdivo

BioThrax (Anthrax Vaccine Adsorbed)

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 Indication Approved: November 23, 2015

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: November 23, 2015

See approval history for Pradaxa

Harvoni (ledipasvir and sofosbuvir) Tablets

Date of Approval: October 10, 2014

Harvoni (ledipasvir and sofosbuvir) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection.

New Indication Approved: November 12, 2015

See approval history for Harvoni

Yervoy (ipilimumab) Injection

Date of Approval: March 25, 2011

Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma.

New Indication Approved: October 28, 2015

See approval history for Yervoy

Opdivo (nivolumab) Injection

Date of Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma and non-small cell lung cancer.

Labeling Revision Approved: October 9, 2015

See approval history for Opdivo

Keytruda (pembrolizumab) for Injection

Date of Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma and metastatic non-small cell lung cancer.

New Indication Approved: October 2, 2015

See approval history for Keytruda

Letairis (ambrisentan) Tablets

Date of Approval: June 15, 2007

Letairis (ambrisentan) is an endothelin receptor antagonist (ERA) indicated for the once-daily oral treatment of pulmonary arterial hypertension.

Labeling Revision Approved: October 2, 2015

See approval history for Letairis

Juvederm (dermal filler)

Date of Approval: June 2, 2006

Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

New Formulation Approved: October 1, 2015

See approval history for Juvederm

Opdivo (nivolumab) Injection

Date of Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma and non-small cell lung cancer.

New Dosage Regimen: September 30, 2015

See approval history for Opdivo

Betaseron (interferon beta-1b) Injection

Date of Approval: July 23, 1993

Betaseron (interferon beta-1b) is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis.

New Dosage Regimen: September 25, 2015

Spiriva Respimat (tiotropium bromide) Inhalation Spray

Date of Approval: September 24, 2014

Spiriva Respimat (tiotropium bromide) is a long-acting muscarinic antagonist (LAMA) indicated for the long-term, maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma.

New Indication Approved: September 15, 2015

See approval history for Spiriva Respimat

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, ulcerative colitis and hidradenitis suppurativa.

New Indication Approved: September 10, 2015

Brilinta (ticagrelor) Tablets

Date of Approval: July 20, 2011

Brilinta (ticagrelor) is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome.

New Indication Approved: September 3, 2015

See approval history for Brilinta

Emend (aprepitant) Capsules

Date of Approval: March 27, 2003

Emend (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist used in combination with other antiemetic agents to prevent and control acute and delayed nausea and vomiting associated with chemotherapy.

Patient Population Altered: August 28, 2015

Aptiom (eslicarbazepine acetate) Tablets

Date of Approval: November 8, 2013

Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in adults with epilepsy.

New Indication Approved: August 27, 2015

See approval history for Aptiom

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.

Patient Population Altered: August 24, 2015

See approval history for Promacta

Procysbi (cysteamine bitartrate) Delayed-Release Capsules

Date of Approval: April 30, 2013

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis.

Patient Population Altered: August 14, 2015

See approval history for Procysbi

OxyContin (oxycodone) Controlled-Release Tablets

Date of Approval: December 12, 1995

OxyContin (oxycodone) is an opioid agonist indicated for the management of moderate to severe pain when a continuous, around-the clock opioid analgesic is needed for an extended period of time.

Patient Population Altered: August 13, 2015

Onsolis (fentanyl) Buccal Soluble Film

Date of Approval: July 16, 2009

Onsolis (fentanyl) is an opioid agonist in a buccal formulation indicated for the management of breakthrough pain in cancer patients.

New Formulation Approved: August 11, 2015

See approval history for Onsolis

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 Indication Approved: August 10, 2015

See approval history for Zubsolv

Finacea (azelaic acid)

Date of Approval: December 24, 2002

Finacea (azelaic acid) is a topical prescription medication used to treat mild to moderate rosacea.

New Dosage Form Approved: July 29, 2015

Kyprolis (carfilzomib) Injection

Date of Approval: July 20, 2012

Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma.

New Indication Approved: July 24, 2015

See approval history for Kyprolis

Dysport (abobotulinumtoxinA) Injection

Date of Approval: April 29, 2009

Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, and for the treatment of upper limb spasticity.

New Indication Approved: July 16, 2015

See approval history for Dysport

Iressa (gefitinib) Tablets

Date of Approval: May 5, 2003

Iressa (gefitinib) is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) gene mutations as detected by an FDA-approved test.

New Indication Approved: July 13, 2015

Fycompa (perampanel) Tablets

Date of Approval: October 22, 2012

Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated as adjunctive therapy for the treatment of partial-onset seizures and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy.

New Indication Approved: June 19, 2015

See approval history for Fycompa

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.

Patient Population Altered: June 12, 2015

See approval history for Promacta

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

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