New Drug Approvals Archive - November 2015

Nucala (mepolizumab) Injection

Date of Approval: November 4, 2015
Company: GlaxoSmithKline plc
Treatment for: Eosinophilic Asthma; Chronic Rhinosinusitis with Nasal Polyps; Eosinophilic Granulomatosis with Polyangiitis; Hypereosinophilic Syndrome

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) used for the treatment of with severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and hypereosinophilic syndrome (HES).

• FDA Approves Nucala (mepolizumab) to Treat Severe Asthma
• 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.

• FDA Approves Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) for HIV
• 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.

• FDA Approves Cotellic (cobimetinib) for the Combination Treatment of Advanced Melanoma
• 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:

• as adjuvant therapy after tumor resection in adult patients with non small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
• for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
• for the treatment of adult patients with metastatic EGFR T790M mutationpositive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

• FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer
• 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.

• FDA Approves Adynovate Modified Antihemophilic Factor for Hemophilia A
• 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.

• FDA Approves Darzalex (daratumumab) for Patients with Previously Treated Multiple Myeloma
• Darzalex (daratumumab) FDA Approval History

Narcan (naloxone) Nasal Spray

Date of Approval: November 18, 2015
Company: Emergent BioSolutions, 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.

• FDA Approves Narcan (naloxone) Nasal Spray to Treat Opioid Overdose
• 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.

• FDA Approves Ninlaro (ixazomib) for Multiple Myeloma
• Ninlaro (ixazomib) FDA Approval History

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.

• FDA Approves Portrazza (necitumumab) for Advanced Squamous Non-Small Cell Lung Cancer
• 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 virus vaccine indicated for the prevention of seasonal influenza in people 65 years of age and older.

• FDA Approves Fluad (influenza vaccine, adjuvanted) for Prevention of Seasonal Influenza
• 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 for the combination treatment of patients with multiple myeloma.

• FDA Approves Empliciti (elotuzumab) for Multiple Myeloma
• Empliciti (elotuzumab) FDA Approval History