New Drug Approvals Archive - 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).

• 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

Harvoni (ledipasvir and sofosbuvir)

New Indication Approved: November 12, 2015

• FDA Approves New Indications for Harvoni to Include Patients with Genotypes 4, 5 and 6 HCV and Patients Co-Infected with HIV
• Harvoni (ledipasvir and sofosbuvir) 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.

• 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: 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.

• 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

Pradaxa (dabigatran etexilate)

New Indication Approved: November 23, 2015

• FDA Approves Pradaxa for Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism after Hip Replacement Surgery
• Pradaxa (dabigatran etexilate) FDA Approval History

BioThrax (Anthrax Vaccine Adsorbed)

New Indication Approved: November 23, 2015

• FDA Approves BioThrax for Use After Known or Suspected Anthrax Exposure

Opdivo (nivolumab)

New Indication Approved: November 23, 2015

• FDA Approves Opdivo to Treat Metastatic Renal Cell Carcinoma
• Opdivo (nivolumab) 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 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 in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

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

Darzalex (daratumumab)

New Indication Approved: November 21, 2016

• Darzalex (daratumumab) Approved by FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy
• Darzalex (daratumumab) FDA Approval History

Adynovate (antihemophilic factor (recombinant) pegylated)

Patient Population Altered: December 22, 2016

• Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical Settings
• Adynovate (antihemophilic factor (recombinant) pegylated) FDA Approval History

Narcan (naloxone)

New Dosage Form Approved: January 24, 2017

• Narcan (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration
• Narcan (naloxone) FDA Approval History

Tagrisso (osimertinib)

Labeling Revision Approved: March 30, 2017

• Tagrisso (osimertinib) Receives FDA Full Approval
• Tagrisso (osimertinib) FDA Approval History

Darzalex (daratumumab)

New Indication Approved: June 16, 2017

• Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
• Darzalex (daratumumab) FDA Approval History

Nucala (mepolizumab)

New Indication Approved: December 12, 2017

• FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)
• Nucala (mepolizumab) FDA Approval History

Tagrisso (osimertinib)

New Indication Approved: April 18, 2018

• FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer
• Tagrisso (osimertinib) FDA Approval History

Darzalex (daratumumab)

New Indication Approved: May 7, 2018

• Janssen Announces Darzalex (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible
• Darzalex (daratumumab) FDA Approval History