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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

Ocrevus (ocrelizumab)

Company: Genentech, Inc.
Date of Approval: March 28, 2017
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal nerve cell damage. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

Ocrevus FDA Approval History

Dupixent (dupilumab) Injection

Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Date of Approval: March 28, 2017
Treatment for: Atopic Dermatitis

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis.

Dupixent FDA Approval History

Zejula (niraparib) Capsules

Company: Tesaro Inc.
Date of Approval: March 27, 2017
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the maintenance treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Zejula FDA Approval History

Symproic (naldemedine) Tablets

Company: Shionogi Inc.
Date of Approval: March 23, 2017
Treatment for: Opioid-Induced Constipation

Symproic (naldemedine) is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation.

Symproic FDA Approval History

Bavencio (avelumab) Injection

Company: EMD Serono, Inc.
Date of Approval: March 23, 2017
Treatment for: Merkel Cell Carcinoma

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC).

Bavencio FDA Approval History

Kisqali (ribociclib) Tablets - formerly LEE011

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 13, 2017
Treatment for: Breast Cancer

Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor indicated for the combination treatment of postmenopausal women with HR+/HER2- metastatic breast cancer.

Kisqali FDA Approval History

Noctiva (desmopressin acetate) Nasal Spray

Company: Serenity Pharmaceuticals, LLC
Date of Approval: March 3, 2017
Treatment for: Nocturia

Noctiva (desmopressin acetate) is vasopressin analog nasal spray indicated for the treatment of nocturia due to nocturnal polyuria.

Noctiva FDA Approval History

Odactra (house dust mite allergen extract) Sublingual Tablets

Company: ALK-Abelló A/S
Date of Approval: March 1, 2017
Treatment for: House Dust Mite Allergies

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.

Odactra FDA Approval History

Xermelo (telotristat ethyl) Tablets

Company: Lexicon Pharmaceuticals, Inc.
Date of Approval: February 28, 2017
Treatment for: Carcinoid Syndrome Diarrhea

Xermelo (telotristat ethyl) is an oral tryptophan hydroxylase inhibitor indicated for use in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.

Xermelo FDA Approval History

Qtern (dapagliflozin and saxagliptin) Tablets

Company: AstraZeneca Pharmaceuticals LP
Date of Approval: February 27, 2017
Treatment for: Diabetes Type 2

Qtern (dapagliflozin and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.

Qtern FDA Approval History

Siliq (brodalumab) Injection

Company: Valeant Pharmaceuticals International, Inc.
Date of Approval: February 15, 2017
Treatment for: Plaque Psoriasis

Siliq (brodalumab) is a human anti-interleukin-17-receptor monoclonal antibody for the treatment of plaque psoriasis.

Siliq FDA Approval History

Parsabiv (etelcalcetide) Injection

Company: Amgen Inc.
Date of Approval: February 7, 2017
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Parsabiv FDA Approval History

AirDuo RespiClick (fluticasone propionate and salmeterol) Inhalation Powder

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: January 27, 2017
Treatment for: Asthma -- Maintenance

AirDuo RespiClick (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

AirDuo RespiClick FDA Approval History

ArmonAir RespiClick (fluticasone propionate) Inhalation Powder

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: January 27, 2017
Treatment for: Asthma -- Maintenance

ArmonAir RespiClick (fluticasone propionate) is an inhaled corticosteroid in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

ArmonAir RespiClick FDA Approval History

Rhofade (oxymetazoline hydrochloride) Cream

Company: Allergan, Inc.
Date of Approval: January 18, 2017
Treatment for: Acne Rosacea

Rhofade (oxymetazoline hydrochloride) is a topical alpha1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

Rhofade FDA Approval History

Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: January 17, 2017
Treatment for: Pain

Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Vantrela ER FDA Approval History
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