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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

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.

Duzallo FDA Approval History

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).

Besponsa FDA Approval History

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.

CaroSpir FDA Approval History

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).

Vyxeos FDA Approval History

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.

Mavyret FDA Approval History

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.

Idhifa FDA Approval History

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.

Vosevi FDA Approval History

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.

Tremfya FDA Approval History

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.

Endari FDA Approval History

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 History

Bevyxxa (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.

Bevyxxa FDA Approval History

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

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).

Rituxan Hycela 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) 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.

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

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.

Rebinyn FDA Approval History
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