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
Get news by email or subscribe to our news feeds.
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.
- FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema - June 23, 2017
- FDA Accepts CSL Behring's BLA for First Subcutaneous Prophylactic Therapy CSL830 to Prevent Hereditary Angioedema Attacks - August 30, 2016
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.
- FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD - June 21, 2017
- FDA Issues Approvable Letter for SPD465 (Triple-Bead Mixed Amphetamine Salts) for the Treatment of ADHD in Adults - May 21, 2007
- Shire Announces Filing of SPD465 for the Treatment of Adult ADHD - July 21, 2006
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.
- Melinta Therapeutics Announces FDA Approval of Baxdela (delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) - June 19, 2017
- Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections - October 24, 2016
- Melinta Therapeutics Raises $70 Million to Support Delafloxacin NDA and Selection of Multi-Drug Resistant Gram-Negative Candidates from RX-04 Platform - February 11, 2014
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.
- Neos Therapeutics Announces FDA Approval of Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets for the Treatment of ADHD in Patients 6 to 17 Years Old - June 19, 2017
- Neos Therapeutics Completes Resubmission of NDA for Cotempla XR-ODT for the Treatment of ADHD - December 20, 2016
- Neos Therapeutics Receives Complete Response Letter From the FDA for Cotempla XR-ODT - November 10, 2015
- Neos Therapeutics Announces Submission of NDA for its Methylphenidate Extended Release Oral Disintegrating Tablet (XR-ODT) for the Treatment of ADHD - January 12, 2015
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.
- Adamis Pharmaceuticals Receives FDA Approval for Symjepi (epinephrine) Pre-Filled Syringe - June 15, 2017
- Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA - January 19, 2017
- Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA - December 16, 2016
- Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA - June 6, 2016
- Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA - January 14, 2016
- Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA - December 7, 2015
- Adamis Pharmaceuticals Provides Regulatory Update on Its Epinephrine Pre-Filled Syringe - August 6, 2015
- Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA - March 27, 2015
- FDA Accepts for Review Adamis’ New Drug Application for Its Epinephrine Pre-Filled Syringe - July 29, 2014
- Adamis Submits New Drug Application to FDA for Its Epinephrine Pre-Filled Syringe - May 29, 2014
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.
- FDA Approves Gleolan (aminolevulinic acid hydrochloride) as an Optical Imaging Agent in Patients with Gliomas - June 6, 2017
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.
- Nicox Receives FDA Approval of Zerviate (cetirizine ophthalmic solution) 0.24% - May 31, 2017
- Nicox Announces PDUFA Date for Zerviate NDA - April 11, 2017
- Nicox Resubmits AC-170 (Zerviate) NDA to the U.S. FDA - March 9, 2017
- Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170 - October 10, 2016
- U.S. FDA grants Priority Review for Nicox’s AC-170 New Drug Application - June 21, 2016
- Nicox submits New Drug Application for AC-170 to U.S. FDA - April 19, 2016
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.
- Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis - May 22, 2017
- Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA - April 28, 2017
- Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis - October 28, 2016
- Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA - January 8, 2016
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.
- FDA Approves Radicava (edaravone) to Treat Amyotrophic Lateral Sclerosis (ALS) - May 5, 2017
- FDA Accepts Mitsubishi Tanabe Pharma's NDA Filing for Edaravone to Treat ALS - August 30, 2016
- Mitsubishi Tanabe Pharma Submits New Drug Application for Edaravone to Treat ALS in the United States - June 22, 2016
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.
- AstraZeneca’s Imfinzi (durvalumab) Receives FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer - May 1, 2017
- US FDA Accepts First Biologics License Application for AstraZeneca’s Durvalumab in Bladder Cancer - December 9, 2016
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.
- FDA Approves Tymlos (abaloparatide) for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture - April 28, 2017
- Radius Health Receives Notification of PDUFA Extension for Abaloparatide-SC - March 10, 2017
- Radius Announces FDA Acceptance for Filing of NDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis - May 31, 2016
- Radius Health Submits NDA to the U.S. FDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis - March 30, 2016
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.
- Takeda Announces FDA Accelerated Approval of Alunbrig (brigatinib) - April 28, 2017
- ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib - October 31, 2016
- ARIAD Completes Rolling Submission of NDA for Brigatinib to the U.S. FDA - August 30, 2016
- ARIAD Initiates Submission of New Drug Application for Brigatinib to the U.S. FDA Ahead of Plan - June 17, 2016
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.
- FDA Approves Rydapt (midostaurin) for FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis - April 28, 2017
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.
- FDA Approves Brineura (cerliponase alfa) for CLN2 Disease, a Form of Batten Disease - April 27, 2017
- BioMarin Announces Update to Brineura (cerliponase alfa) Program for Treatment of CLN2 Disease, a Form of Batten Disease - September 6, 2016
- FDA Accepts BLA for BioMarin’s Cerliponase Alfa for CLN2 Disease, Form of Batten Disease - July 27, 2016
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.
- FDA Approves Xatmep (methotrexate) Oral Solution - April 26, 2017
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.
- FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade - April 24, 2017
- Merck Announces FDA Accepts Samsung Bioepis’ BLA for SB2 (infliximab), an Investigational Biosimilar of Remicade - May 23, 2016
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.
- Inspirion Delivery Sciences Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate Release Tablets with Abuse-Deterrent Label Claims - April 26, 2017
Ingrezza (valbenazine) Capsules
Company: Neurocrine Biosciences, Inc.
Date of Approval: April 11, 2017
Treatment for: Tardive Dyskinesia
Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor for the treatment of tardive dyskinesia.
- Neurocrine Announces FDA Approval of Ingrezza (valbenazine) as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD) - April 11, 2017
- Neurocrine Provides Update on FDA Advisory Committee for Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia - January 5, 2017
- Neurocrine Announces FDA Advisory Committee Meeting to Review Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia - November 29, 2016
- Neurocrine Announces Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by FDA - October 11, 2016
- Neurocrine Announces FDA Conditional Acceptance of Proprietary Name Ingrezza for VMAT2 Inhibitor Valbenazine - August 31, 2016
- Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia - August 29, 2016
Austedo (deutetrabenazine) Tablets - formerly SD-809
Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: April 3, 2017
Treatment for: Huntington Disease
Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.
- Teva Announces FDA Approval of Austedo (deutetrabenazine) for the Treatment of Chorea Associated with Huntington’s Disease - April 3, 2017
- Teva Announces FDA Acceptance of Resubmitted NDA for SD-809 for Treatment of Chorea Associated with Huntington Disease - October 20, 2016
- Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease - May 31, 2016
- Teva Announces Breakthrough Therapy Designation for SD-809 Granted by FDA for the Treatment of Tardive Dyskinesia - November 9, 2015
- Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease - August 12, 2015
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.
- FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis - March 28, 2017
- FDA Extends Review of Application for Ocrevus (ocrelizumab) - December 20, 2016
- FDA Grants Priority Review for Genentech’s Ocrevus (ocrelizumab) Biologics License Application - June 28, 2016
