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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

Tymlos (abaloparatide) Injection

Company: Radius Health, Inc.
Date of Approval: April 28, 2017
Treatment for: Osteoporosis

Tymlos (abaloparatide) is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of postmenopausal women with osteoporosis.

Tymlos FDA Approval History

Alunbrig (brigatinib) Tablets

Company: Ariad Pharmaceuticals, Inc.
Date of Approval: April 28, 2017
Treatment for: Non-Small Cell Lung Cancer

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.

Alunbrig FDA Approval History

Rydapt (midostaurin) Capsules - formerly PKC412

Company: Novartis Pharmaceuticals Corporation
Date of Approval: April 28, 2017
Treatment for: Acute Myeloid Leukemia, Mastocytosis

Rydapt (midostaurin) is an oral, multi-targeted kinase inhibitor for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, and for the treatment of advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.

Rydapt FDA Approval History

Brineura (cerliponase alfa) Injection

Company: BioMarin Pharmaceutical Inc.
Date of Approval: April 27, 2017
Treatment for: CLN2 Disease

Brineura (cerliponase alfa) is an enzyme replacement therapy for the restoration of tripeptidyl peptidase-1 (TPP1) enzyme activity in patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), or TPP1 deficiency, a form of Batten disease.

Brineura FDA Approval History

Xatmep (methotrexate) Oral Solution

Company: Silvergate Pharmaceuticals, Inc.
Date of Approval: April 25, 2017
Treatment for: Acute Lymphoblastic Leukemia, Juvenile Idiopathic Arthritis

Xatmep (methotrexate) is a folate analog metabolic inhibitor in an oral solution formulation indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and for the management of pediatric patients with active polyarticular juvenile idiopathic arthritis.

Xatmep FDA Approval History

Renflexis (infliximab-abda) Injection

Company: Samsung Bioepis Co., Ltd.
Date of Approval: April 21, 2017
Treatment for: Crohn's Disease -- Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Renflexis (infliximab-abda) 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.

Renflexis FDA Approval History

RoxyBond (oxycodone hydrochloride) Tablets

Company: Inspirion Delivery Sciences, LLC
Date of Approval: April 20, 2017
Treatment for: Pain

RoxyBond (oxycodone hydrochloride) is an immediate-release, abuse-deterrent, narcotic analgesic formulation for the management of severe pain.

RoxyBond FDA Approval History

Ocrevus (ocrelizumab) Injection

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
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