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New Drug Approvals Archive - November 2015

November 2015

Nucala (mepolizumab) Injection

Date of Approval: November 4, 2015
Company: GlaxoSmithKline plc
Treatment for: Asthma, Churg-Strauss Allergic Angiitis

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma, and for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).

Read more: Nucala (mepolizumab) FDA Approval History

Genvoya (cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: November 5, 2015
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or E/C/F/TAF) is an antiretroviral combination for the treatment of HIV infection.

Read more: Genvoya (cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide) FDA Approval History

Cotellic (cobimetinib) Tablets

Date of Approval: November 10, 2015
Company: Genentech, Inc.
Treatment for: Melanoma - Metastatic

Cotellic (cobimetinib) is a kinase inhibitor indicated for use in combination with vemurafenib for the treatment of advanced melanoma with a BRAF V600E or V600K mutation.

Read more: Cotellic (cobimetinib) FDA Approval History

Tagrisso (osimertinib) Tablets

Date of Approval: November 13, 2015
Company: AstraZeneca Pharmaceuticals
Treatment for: Non-Small Cell Lung Cancer

Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated for the treatment of patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has worsened on or after EGFR-TKI therapy.

Read more: Tagrisso (osimertinib) FDA Approval History

Adynovate (antihemophilic factor (recombinant) pegylated)

Date of Approval: November 13, 2015
Company: Baxalta Incorporated
Treatment for: Hemophilia A

Adynovate (antihemophilic factor (recombinant) pegylated) is a human antihemophilic factor indicated for the control and prevention of bleeding episodes in patients with hemophilia A.

Read more: Adynovate (antihemophilic factor (recombinant) pegylated) FDA Approval History

Darzalex (daratumumab) Injection

Date of Approval: November 16, 2015
Company: Janssen Biotech, Inc.
Treatment for: Multiple Myeloma

Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.

Read more: Darzalex (daratumumab) FDA Approval History

Narcan (naloxone) Nasal Spray

Date of Approval: November 18, 2015
Company: Adapt Pharma, Inc.
Treatment for: Opioid Overdose

Narcan Nasal Spray (naloxone) is an intranasal opioid antagonist formulation indicated for the emergency treatment of known or suspected opioid overdose.

Read more: Narcan (naloxone) FDA Approval History

Ninlaro (ixazomib) Capsules

Date of Approval: November 20, 2015
Company: Takeda Pharmaceutical Company Limited
Treatment for: Multiple Myeloma

Ninlaro (ixazomib) is an oral proteasome inhibitor indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Read more: Ninlaro (ixazomib) FDA Approval History

BioThrax (Anthrax Vaccine Adsorbed)

New Indication Approved: November 23, 2015

Portrazza (necitumumab) Injection

Date of Approval: November 24, 2015
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer

Portrazza (necitumumab) is an epidermal growth factor receptor (EGFR) antagonist indicated in combination with gemcitabine and cisplatin for the treatment of patients with metastatic squamous non-small cell lung cancer.

Read more: Portrazza (necitumumab) FDA Approval History

Fluad (influenza vaccine, adjuvanted) Injection

Date of Approval: November 24, 2015
Company: Seqirus
Treatment for: Influenza Prophylaxis

Fluad (influenza vaccine, adjuvanted) is an inactivated influenza vaccine indicated for the prevention of seasonal influenza in people 65 years of age and older.

Read more: Fluad (influenza vaccine, adjuvanted) FDA Approval History

Empliciti (elotuzumab) Injection

Date of Approval: November 30, 2015
Company: Bristol-Myers Squibb Company and AbbVie
Treatment for: Multiple Myeloma

Empliciti (elotuzumab) is a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Read more: Empliciti (elotuzumab) FDA Approval History

Tagrisso (osimertinib)

Labeling Revision Approved: March 30, 2017

Read more: Tagrisso (osimertinib) FDA Approval History

New Drug Approvals Archive