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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Ixifi (infliximab-qbtx) Injection

Company: Pfizer Inc.
Date of Approval: December 13, 2017
Treatment for: Crohn's Disease -- Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Ixifi (infliximab-qbtx) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Ixifi FDA Approval History

Admelog (insulin lispro) Injection

Company: Sanofi-Aventis U.S. LLC
Date of Approval: December 11, 2017
Treatment for: Diabetes Type 1, Diabetes Type 2

Admelog (insulin lispro) is a follow-on insulin product (referenced to Humalog) for the treatment of patients with type 1 and type 2 diabetes.

Admelog FDA Approval History

Sinuva (mometasone furoate) Sinus Implant

Company: Intersect ENT, Inc.
Date of Approval: December 8, 2017
Treatment for: Nasal Polyps

Sinuva (mometasone furoate) is a corticosteroid-eluting sinus implant indicated for the treatment of recurrent nasal polyp disease.

Sinuva FDA Approval History

Lonhala Magnair (glycopyrrolate) Inhalation Solution

Company: Sunovion Pharmaceuticals Inc.
Date of Approval: December 5, 2017
Treatment for: Chronic Obstructive Pulmonary Disease

Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Lonhala Magnair FDA Approval History

Ozempic (semaglutide) Injection

Company: Novo Nordisk
Date of Approval: December 5, 2017
Treatment for: Diabetes Type 2

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the treatment of adults with type 2 diabetes.

Ozempic FDA Approval History

Ogivri (trastuzumab-dkst) - formerly MYL-1401O

Company: Mylan GmbH
Date of Approval: December 1, 2017
Treatment for: Breast Cancer, Stomach Cancer

Ogivri (trastuzumab-dkst) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing stomach cancer.

Ogivri FDA Approval History

Sublocade (buprenorphine) Sustained-Release Injection - formerly RBP-6000

Company: Indivior PLC
Date of Approval: November 30, 2017
Treatment for: Opioid Use Disorder

Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD).

Sublocade FDA Approval History

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution

Company: Ferring Pharmaceuticals
Date of Approval: November 28, 2017
Treatment for: Bowel Preparation

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) is a stimulant laxative and osmotic laxative combination indicated for cleansing of the colon as a preparation for colonoscopy.

Clenpiq FDA Approval History

Impoyz (clobetasol propionate) Cream

Company: Dr. Reddy's Laboratories, Inc.
Date of Approval: November 28, 2017
Treatment for: Plaque Psoriasis

Impoyz (clobetasol propionate) is a high potency topical corticosteroid indicated for the treatment of moderate to severe plaque psoriasis.

Impoyz FDA Approval History

Juluca (dolutegravir and rilpivirine) Tablets

Company: ViiV Healthcare
Date of Approval: November 21, 2017
Treatment for: HIV Infection

Juluca (dolutegravir and rilpivirine) is a single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and rilpivirine (Edurant) for the maintenance treatment of virologically suppressed HIV-1 infection.

Juluca FDA Approval History

Hemlibra (emicizumab-kxwh) Injection

Company: Genentech, Inc.
Date of Approval: November 16, 2017
Treatment for: Hemophilia A with Inhibitors

Hemlibra (emicizumab-kxwh) is a bispecific factor IXa- and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Hemlibra FDA Approval History

Mepsevii (vestronidase alfa) Injection

Company: Ultragenyx Pharmaceutical Inc.
Date of Approval: November 15, 2017
Treatment for: Mucopolysaccharidosis Type VII

Mepsevii (vestronidase alfa) is a recombinant human lysosomal beta glucuronidase indicated for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).

Mepsevii FDA Approval History

Fasenra (benralizumab) Injection

Company: AstraZeneca
Date of Approval: November 14, 2017
Treatment for: Asthma

Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody indicated for the treatment of patients with severe eosinophilic asthma.

Fasenra FDA Approval History

Abilify MyCite (aripiprazole) Tablets with Sensor - formerly Abilify Digital

Company: Otsuka Pharmaceutical Co., Ltd
Date of Approval: November 13, 2017
Treatment for: Schizophrenia, Bipolar Disorder, Depression

Abilify MyCite (aripiprazole) is a tablet formulation of the approved atypical antipsychotic aripiprazole embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application to measure adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.

Abilify MyCite FDA Approval History

Cinvanti (aprepitant) Injection

Company: Heron Therapeutics, Inc.
Date of Approval: November 9, 2017
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK 1) receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Cinvanti FDA Approval History

Prevymis (letermovir) Tablets and Injection

Company: Merck & Co., Inc.
Date of Approval: November 8, 2017
Treatment for: CMV Prophylaxis

Prevymis (letermovir) is a CMV DNA terminase complex inhibitor indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult allogeneic hematopoietic stem cell transplant patients.

Prevymis FDA Approval History

Calquence (acalabrutinib) Capsules

Company: AstraZeneca
Date of Approval: October 31, 2017
Treatment for: Mantle Cell Lymphoma

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL).

Calquence FDA Approval History

Shingrix (zoster vaccine recombinant, adjuvanted) Injection

Company: GlaxoSmithKline
Date of Approval: October 20, 2017
Treatment for: Herpes Zoster -- Prophylaxis

Shingrix (zoster vaccine recombinant, adjuvanted) is a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

Shingrix FDA Approval History
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