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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

Cequa (cyclosporine) Ophthalmic Solution

Company: Sun Pharmaceutical Industries Inc.
Date of Approval: August 14, 2018
Treatment for: Keratoconjunctivitis Sicca

Cequa (cyclosporine) ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with dry eye disease (keratoconjunctivitis sicca).

Onpattro (patisiran) Injection

Company: Alnylam Pharmaceuticals, Inc.
Date of Approval: August 10, 2018
Treatment for: Hereditary Transthyretin-Mediated Amyloidosis (hATTR)

Onpattro (patisiran) is a small interfering ribonucleic acid (siRNA) therapeutic for the treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR).

Galafold (migalastat) Capsules

Company: Amicus Therapeutics
Date of Approval: August 10, 2018
Treatment for: Fabry Disease

Galafold (migalastat) is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant.

Annovera (ethinyl estradiol and segesterone acetate) Vaginal System

Company: The Population Council
Date of Approval: August 10, 2018
Treatment for: Contraception

Annovera (ethinyl estradiol and segesterone acetate) is an estrogen and progestin vaginal contraceptive system indicated to prevent pregnancy for up to a year.

Poteligeo (mogamulizumab-kpkc) Injection

Company: Kyowa Kirin, Inc.
Date of Approval: August 8, 2018
Treatment for: Mycosis Fungoides; Sézary Syndrome

Poteligeo (mogamulizumab-kpkc) is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).

Arakoda (tafenoquine) Tablets

Company: 60 Degrees Pharmaceuticals, LLC
Date of Approval: August 8, 2018
Treatment for: Malaria Prophylaxis

Arakoda (tafenoquine) is an 8-aminoquinoline antimalarial drug indicated for the prophylaxis of malaria in patients aged 18 years and older.

Jornay PM (methylphenidate hydrochloride) Extended-Release Capsules

Company: Ironshore Pharmaceuticals & Development, Inc.
Date of Approval: August 8, 2018
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Jornay PM (methylphenidate hydrochloride) is a once-daily formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Mulpleta (lusutrombopag) Tablets

Company: Shionogi Inc.
Date of Approval: July 31, 2018
Treatment for: Thrombocytopenia

Mulpleta (lusutrombopag) is a once-daily, orally administered, thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical or dental procedure.

Azedra (iobenguane I 131) Injection

Company: Progenics Pharmaceuticals, Inc.
Date of Approval: July 30, 2018
Treatment for: Pheochromocytoma; Paraganglioma

Azedra (iobenguane I 131) is a radioactive therapeutic agent for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma.

Perseris (risperidone) for Extended-Release Injectable Suspension

Company: Indivior Inc.
Date of Approval: July 27, 2018
Treatment for: Schizophrenia

Perseris (risperidone) is a once-monthly, subcutaneous formulation of the approved atypical antipsychotic risperidone indicated for the treatment of schizophrenia in adults.

Orilissa (elagolix) Tablets

Company: AbbVie Inc.
Date of Approval: July 23, 2018
Treatment for: Endometriosis

Orilissa (elagolix) is an orally administered gonadotropin-releasing hormone (GnRH) antagonist for the management of moderate to severe pain associated with endometriosis.

Krintafel (tafenoquine) Tablets

Company: GlaxoSmithKline
Date of Approval: July 20, 2018
Treatment for: Malaria

Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

Tibsovo (ivosidenib) Tablets

Company: Agios Pharmaceuticals, Inc.
Date of Approval: July 20, 2018
Treatment for: Acute Myeloid Leukemia

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with relapsed or refractory acute myeloid leukemia with an IDH1 mutation.

Nivestym (filgrastim-aafi) Injection

Company: Pfizer Inc.
Date of Approval: July 20, 2018
Treatment for: Neutropenia Associated with Chemotherapy, Febrile Neutropenia

Nivestym (filgrastim-aafi) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.

Symtuza (cobicistat, darunavir, emtricitabine and tenofovir alafenamide) Tablets

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: July 17, 2018
Treatment for: HIV Infection

Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide) is a once daily, single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

TPOXX (tecovirimat) Capsules

Company: SIGA Technologies, Inc.
Date of Approval: July 13, 2018
Treatment for: Smallpox

TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease.

Qbrexza (glycopyrronium) Cloth for Topical Use

Company: Dermira, Inc.
Date of Approval: June 28, 2018
Treatment for: Hyperhidrosis

Qbrexza (glycopyrronium) is a topical anticholinergic contained in a single-use, pre-moistened, medicated cloth for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older.

Braftovi (encorafenib) Capsules

Company: Array BioPharma Inc.
Date of Approval: June 27, 2018
Treatment for: Melanoma - Metastatic

Braftovi (encorafenib) is a kinase inhibitor indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Mektovi (binimetinib) Tablets

Company: Array BioPharma Inc.
Date of Approval: June 27, 2018
Treatment for: Melanoma - Metastatic

Mektovi (binimetinib) is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Zemdri (plazomicin) Injection

Company: Achaogen, Inc.
Date of Approval: June 25, 2018
Treatment for: Urinary Tract Infection

Zemdri (plazomicin) is an aminoglycoside antibacterial for the treatment of complicated urinary tract infections.

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