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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

Haegarda (C1 esterase inhibitor (human)) Subcutaneous Injection - formerly CSL830

Company: CSL Behring
Date of Approval: June 22, 2017
Treatment for: Hereditary Angioedema

Haegarda (C1 esterase inhibitor (human)) is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy to prevent Hereditary Angioedema (HAE) attacks.

Haegarda FDA Approval History

Mydayis (amphetamine mixed salts) - formerly SPD465

Company: Shire US, Inc.
Date of Approval: June 20, 2017
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Mydayis (amphetamine mixed salts) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.

Mydayis FDA Approval History

Baxdela (delafloxacin)

Company: Melinta Therapeutics
Date of Approval: June 19, 2017
Treatment for: Skin and Structure Infection

Baxdela (delafloxacin) is a fluoroquinolone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.

Baxdela FDA Approval History

Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets

Company: Neos Therapeutics, Inc.
Date of Approval: June 19, 2017
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

Cotempla XR-ODT (methylphenidate) is a once-daily, extended-release, orally disintegrating tablet formulation of the central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Cotempla XR-ODT FDA Approval History

Symjepi (epinephrine) Injection

Company: Adamis Pharmaceuticals Corporation
Date of Approval: June 15, 2017
Treatment for: Allergic Reaction

Symjepi (epinephrine) is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis.

Symjepi FDA Approval History

Gleolan (aminolevulinic acid hydrochloride) Oral Solution

Company: NX Development Corp.
Date of Approval: June 6, 2017
Treatment for: Optical Imaging During Glioma Surgery

Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent indicated for use in patients with glioma as an adjunct for the visualization of malignant tissue during surgery.

Gleolan FDA Approval History

Zerviate (cetirizine hydrochloride) Ophthalmic Solution - formerly AC-170

Company: Nicox Ophthalmics, Inc.
Date of Approval: May 30, 2017
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.

Zerviate FDA Approval History

Kevzara (sarilumab) Injection

Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Date of Approval: May 22, 2017
Treatment for: Rheumatoid Arthritis

Kevzara (sarilumab) is an interleukin-6 receptor (IL-6R) antibody for the treatment of adults with rheumatoid arthritis.

Kevzara FDA Approval History

Radicava (edaravone) Injection

Company: Mitsubishi Tanabe Pharma
Date of Approval: May 5, 2017
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.

Radicava FDA Approval History

Imfinzi (durvalumab) Injection

Company: AstraZeneca Pharmaceuticals LP
Date of Approval: May 1, 2017
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.

Imfinzi FDA Approval History

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: Takeda Pharmaceuticals U.S.A., 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
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