Skip to Content

New Drug Approvals Archive - May 2017

May 2017

May 1	Imfinzi (durvalumab) Injection Date of Approval: May 1, 2017 Company: AstraZeneca 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 Imfinzi (durvalumab) FDA Approval History
May 5	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. FDA Approves Radicava (edaravone) to Treat Amyotrophic Lateral Sclerosis (ALS) Radicava (edaravone) FDA Approval History
May 9	Bavencio (avelumab) New Indication Approved: May 9, 2017 Treatment for: Merkel Cell Carcinoma; Urothelial Carcinoma FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma Bavencio (avelumab) FDA Approval History
May 10	Keytruda (pembrolizumab) 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 Keytruda (pembrolizumab) FDA Approval History
May 17	Kalydeco (ivacaftor) New Indication Approved: May 17, 2017 FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis Kalydeco (ivacaftor) FDA Approval History
May 18	Keytruda (pembrolizumab) New Indication Approved: May 18, 2017 FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma Keytruda (pembrolizumab) FDA Approval History
May 22	Actemra (tocilizumab) New Indication Approved: May 22, 2017 FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis Actemra (tocilizumab) FDA Approval History
May 22	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. Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis Kevzara (sarilumab) FDA Approval History
May 23	Keytruda (pembrolizumab) New Indication Approved: May 23, 2017 FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature Keytruda (pembrolizumab) FDA Approval History
May 26	Zykadia (ceritinib) 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) Zykadia (ceritinib) FDA Approval History
May 30	Isentress (raltegravir) 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 Isentress (raltegravir) FDA Approval History
May 31	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 Rebinyn (coagulation factor IX (recombinant), glycopegylated) FDA Approval History
May 30	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. Nicox Receives FDA Approval of Zerviate (cetirizine ophthalmic solution) 0.24% Zerviate (cetirizine hydrochloride) FDA Approval History

New Drug Approvals Archive

2017

January, February, March, April, May, June, July

2016

January, February, March, April, May, June, July, August, September, October, November, December

2015

January, February, March, April, May, June, July, August, September, October, November, December

2014

January, February, March, April, May, June, July, August, September, October, November, December

2013

January, February, March, April, May, June, July, August, September, October, November, December

2012

January, February, March, April, May, June, July, August, September, October, November, December

2011

January, February, March, April, May, June, July, August, October, November, December

2010

January, February, March, April, May, June, July, August, September, October, November, December

2009

January, February, March, April, May, June, July, August, September, October, November, December

2008

January, February, March, April, May, June, July, August, September, October, November, December

2007

January, February, March, April, May, June, July, August, September, October, November, December

2006

January, February, March, April, May, June, July, August, September, October, November, December

2005

January, February, March, April, May, June, July, August, September, October, November, December

2004

January, February, March, April, May, June, July, August, September, October, November, December

2003

January, February, March, April, May, June, July, August, September, October, November, December

2002

January, February, April, July, August, September, October, November, December

More News Resources

FDA Consumer Updates

More FDA updates

Recently Approved

Tremfya Tremfya (guselkumab) is an interleukin-23 blocker indicated for the treatment of moderate-to-severe...
Endari Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid...
Triptodur Triptodur (triptorelin) is a gonadotropin releasing hormone (GnRH) agonist indicated for the...
Bevyxxa Bevyxxa (betrixaban) is an oral, once-daily Factor Xa inhibitor anticoagulant for the...

Drugs.com Pill Reminder

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include Micromedex® (updated July 5th, 2017), Cerner Multum™ (updated July 13th, 2017), Wolters Kluwer™ (updated July 5th, 2017) and others. To view content sources and attributions, please refer to our editorial policy.