New Drug Approvals Archive - May 2017
Imfinzi (durvalumab) Injection
Date of Approval: May 1, 2017
Treatment for: Urothelial Carcinoma
Imfinzi (durvalumab) is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
- AstraZeneca’s Imfinzi (durvalumab) Receives FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer
Read more: Imfinzi (durvalumab) FDA Approval History
Radicava (edaravone) Injection
Date of Approval: May 5, 2017
Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis
Radicava (edaravone) is a free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.
Read more: Radicava (edaravone) FDA Approval History
New Indication Approved: May 9, 2017
Treatment for: Merkel Cell Carcinoma; Urothelial Carcinoma
Read more: Bavencio (avelumab) FDA Approval History
New Indication Approved: May 10, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) as First-Line Combination Therapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective of PD-L1 Expression
New Indication Approved: May 17, 2017
Read more: Kalydeco (ivacaftor) FDA Approval History
New Indication Approved: May 18, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma
New Indication Approved: May 22, 2017
Read more: Actemra (tocilizumab) FDA Approval History
Kevzara (sarilumab) Injection
Date of Approval: May 22, 2017
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis
Kevzara (sarilumab) is an interleukin-6 receptor (IL-6R) antibody for the treatment of adults with rheumatoid arthritis.
Read more: Kevzara (sarilumab) FDA Approval History
New Indication Approved: May 23, 2017
- FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature
New Indication Approved: May 26, 2017
- Novartis Receives FDA Approval for Expanded Use of Zykadia in First-Line ALK-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
Read more: Zykadia (ceritinib) FDA Approval History
New Dosage Form Approved: May 26, 2017
- Merck Receives FDA Approval of Isentress HD (raltegravir), a New Once-Daily Option for the Combination Treatment of HIV-1 Infection in Appropriate Patients
Read more: Isentress (raltegravir) FDA Approval History
Rebinyn (coagulation factor IX (recombinant), glycopegylated) Injection
Date of Approval: May 31, 2017
Company: Novo Nordisk
Treatment for: Hemophilia B
Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with hemophilia B.
- FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B
Zerviate (cetirizine hydrochloride) Ophthalmic Solution - formerly AC-170
Date of Approval: May 30, 2017
Company: Nicox S.A.
Treatment for: Allergic Conjunctivitis
Zerviate (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.