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New Drug Approvals Archive - May 2017

May 2017

Imfinzi (durvalumab) Injection

Date of Approval: May 1, 2017
Company: AstraZeneca
Treatment for: Urothelial Carcinoma, Non-Small Cell Lung Cancer

Imfinzi (durvalumab) is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody for the treatment of patients with metastatic urothelial carcinoma and for the treatment of patients with unresectable non-small cell lung cancer that has not progressed after chemoradiation.

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

Bavencio (avelumab)

New Indication Approved: May 9, 2017
Treatment for: Merkel Cell Carcinoma; Urothelial Carcinoma

Read more: Bavencio (avelumab) 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

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.

Read more: Rebinyn (coagulation factor IX (recombinant), glycopegylated) FDA Approval History

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.

Read more: Zerviate (cetirizine hydrochloride) FDA Approval History

New Drug Approvals Archive