Skip to Content

New Drug Approvals Archive - May 2017

See also: New Indications and Dosage Forms for May 2017

May 2017

Imfinzi (durvalumab) Injection

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

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

  • for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
    • have disease progression during or following platinum-containing chemotherapy.
    • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.
    This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
  • in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

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.

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 (IL-6) receptor antagonist indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

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.

Zerviate (cetirizine hydrochloride) Ophthalmic Solution

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.

New Drug Approvals Archive

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.