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
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Duzallo (allopurinol and lesinurad) Tablets
Company: Ironwood Pharmaceuticals, Inc.
Date of Approval: August 21, 2017
Treatment for: Gout
Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination for the treatment of hyperuricemia in patients with uncontrolled gout.
- FDA Approves Duzallo (lesinurad and allopurinol) for Hyperuricemia in Patients with Uncontrolled Gout - August 21, 2017
- Ironwood Announces New Drug Application for Duzallo (Fixed-Dose Combination of Lesinurad and Allopurinol) Has Been Accepted for FDA Review - January 4, 2017
Besponsa (inotuzumab ozogamicin) for Injection
Company: Pfizer Inc.
Date of Approval: August 17, 2017
Treatment for: Acute Lymphoblastic Leukemia
Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
- FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia - August 17, 2017
- Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration - February 21, 2017
CaroSpir (spironolactone) Oral Suspension
Company: CMP Pharma, Inc.
Date of Approval: August 4, 2017
Treatment for: Congestive Heart Failure, Edema, Hypertension
CaroSpir (spironolactone) is an oral suspension formulation of the potassium-sparing diuretic spironolactone indicated for the treatment of heart failure, management of edema, and for use as an add-on therapy in the treatment of hypertension.
- CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension - August 7, 2017
Vyxeos (cytarabine and daunorubicin) Injection
Company: Jazz Pharmaceuticals plc
Date of Approval: August 3, 2017
Treatment for: Acute Myeloid Leukemia
Vyxeos (cytarabine and daunorubicin liposome injection) is a liposomal combination of cytarabine, a nucleoside metabolic inhibitor, and daunorubicin, an anthracycline topoisomerase inhibitor, indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
- FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia - August 3, 2017
- Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status - May 31, 2017
- Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia - April 3, 2017
- Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017 - October 3, 2016
Mavyret (glecaprevir and pibrentasvir) Tablets
Company: AbbVie Inc.
Date of Approval: August 3, 2017
Treatment for: Chronic Hepatitis C
Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.
- FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C - August 3, 2017
- U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) - February 2, 2017
- AbbVie Submits NDA to FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C - December 19, 2016
Idhifa (enasidenib) Tablets
Company: Celgene Corporation
Date of Approval: August 1, 2017
Treatment for: Acute Myeloid Leukemia
Idhifa (enasidenib) is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.
- FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation - August 1, 2017
- FDA Accepts New Drug Application and Grants Priority Review for Enasidenib in Relapsed or Refractory AML with an IDH2 Mutation - March 7, 2017
Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Tablets
Company: Gilead Sciences, Inc.
Date of Approval: July 18, 2017
Treatment for: Chronic Hepatitis C
Vosevi (sofosbuvir, velpatasvir and voxilaprevir or SOF/VEL/VOX) is a fixed-dose combination of a nucleotide analog NS5B polymerase inhibitor (SOF), a pangenotypic NS5A inhibitor (VEL), and a pangenotypic NS3/4A protease inhibitor (VOX) for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.
- FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus - July 18, 2017
- Gilead Submits NDA to FDA for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir - December 8, 2016
Nerlynx (neratinib) Tablets
Company: Puma Biotechnology, Inc.
Date of Approval: July 17, 2017
Treatment for: Breast Cancer -- Adjuvant
Nerlynx (neratinib) is a tyrosine kinase inhibitor for the extended adjuvant treatment of early-stage HER2-positive breast cancer.
- FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer - July 17, 2017
- Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib - May 24, 2017
- Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - April 17, 2017
- Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - September 20, 2016
- Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer - July 21, 2016
Tremfya (guselkumab) Injection
Company: Janssen Biotech, Inc.
Date of Approval: July 13, 2017
Treatment for: Plaque Psoriasis
Tremfya (guselkumab) is an interleukin-23 blocker indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis - July 13, 2017
- Janssen Submits Application to FDA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate to Severe Plaque Psoriasis - November 17, 2016
Endari (L-glutamine) Oral Powder
Company: Emmaus Life Sciences Inc.
Date of Approval: July 7, 2017
Treatment for: Sickle Cell Anemia
Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid formulation to relieve pain, swelling and other complications of sickle cell anemia.
- FDA Approves Endari (L-glutamine oral powder) for Sickle Cell Disease - July 8, 2017
- FDA Advisory Committee Recommends Approval of Endari from Emmaus Life Sciences for the Treatment of Sickle Cell Disease - May 24, 2017
- Emmaus’ New Drug Application for Sickle Cell Disease Accepted for Review by FDA - November 8, 2016
Triptodur (triptorelin) Injection
Company: Arbor Pharmaceuticals, LLC
Date of Approval: June 29, 2017
Treatment for: Precocious Puberty
Triptodur (triptorelin) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty.
Triptodur FDA Approval HistoryBevyxxa (betrixaban) Capsules
Company: Portola Pharmaceuticals, Inc.
Date of Approval: June 23, 2017
Treatment for: Prevention of Venous Thromboembolism
Bevyxxa (betrixaban) is an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized for an acute medical illness.
- FDA Approves Bevyxxa (betrixaban) for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients - June 23, 2017
- Portola Pharmaceuticals Announces FDA Accepts NDA for Priority Review for Oral, Factor Xa Inhibitor Anticoagulant Betrixaban - December 23, 2016
- Portola Pharmaceuticals Submits NDA to U.S. FDA for Betrixaban for Extended Duration Prophylaxis of Venous Thromboembolism in Acute Medically Ill Patients - October 25, 2016
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
Rituxan Hycela (rituximab and hyaluronidase human) Injection
Company: Genentech, Inc.
Date of Approval: June 22, 2017
Treatment for: Follicular Lymphoma; Diffuse Large B-Cell Lymphoma; Chronic Lymphocytic Leukemia
Rituxan Hycela (rituximab and hyaluronidase human) is a subcutaneous monoclonal antibody and hyaluronidase human formulation for the treatment of adult patients with follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).
- FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers - June 22, 2017
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) Tablets and Injection
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
Rebinyn (coagulation factor IX (recombinant), glycopegylated) Injection
Company: Novo Nordisk
Date of Approval: May 31, 2017
Treatment for: Hemophilia B
Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with hemophilia B.
- FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B - May 31, 2017
- FDA Advisory Committee Discusses Biologics License Application (BLA) for Nonacog Beta Pegol for the Treatment of People with Hemophilia B - April 4, 2017
