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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

Talzenna (talazoparib) Capsules

Company: Pfizer Inc.
Date of Approval: October 16, 2018
Treatment for: Breast Cancer

Talzenna (talazoparib) is an oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.

Yutiq (fluocinolone acetonide) Intravitreal Implant

Company: EyePoint Pharmaceuticals, Inc.
Date of Approval: October 12, 2018
Treatment for: Non-Infectious Posterior Segment Uveitis

Yutiq (fluocinolone acetonide) is a corticosteroid intravitreal implant indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Tegsedi (inotersen) Injection

Company: Ionis Pharmaceuticals, Inc.
Date of Approval: October 5, 2018
Treatment for: Amyloidogenic Transthyretin Amyloidosis

Tegsedi (inotersen) is an antisense oligonucleotide inhibitor of the transthyretin (TTR) protein for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Revcovi (elapegademase-lvlr) Injection

Company: Leadiant Biosciences, Inc.
Date of Approval: October 5, 2018
Treatment for: Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID).

Nuzyra (omadacycline) for Injection and Tablets

Company: Paratek Pharmaceuticals, Inc.
Date of Approval: October 2, 2018
Treatment for: Skin and Structure Infection, Pneumonia

Nuzyra (omadacycline) is an aminomethylcycline tetracycline antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Seysara (sarecycline) Tablets

Company: Almirall, S.A.
Date of Approval: October 1, 2018
Treatment for: Acne

Seysara (sarecycline) is an oral, narrow spectrum tetracycline-derived antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Xyosted (testosterone enanthate) Subcutaneous Injection

Company: Antares Pharma, Inc.
Date of Approval: September 28, 2018
Treatment for: Hypogonadism -- Male

Xyosted (testosterone enanthate) is a self-administered, subcutaneous injection formulation of the androgen testosterone for the treatment of male hypogonadism, also known as testosterone deficiency or Low T.

Libtayo (cemiplimab-rwlc) Injection

Company: Sanofi
Date of Approval: September 28, 2018
Treatment for: Squamous Cell Carcinoma

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC).

Arikayce (amikacin liposome) Inhalation Suspension

Company: Insmed, Inc.
Date of Approval: September 28, 2018
Treatment for: Mycobacterium Avium Complex (MAC) Lung Disease

Arikayce (amikacin liposome inhalation suspension) is an aminoglycoside antibacterial indicated for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options.

Vizimpro (dacomitinib) Tablets

Company: Pfizer Inc.
Date of Approval: September 27, 2018
Treatment for: Non-Small Cell Lung Cancer

Vizimpro (dacomitinib) is an oral, once-daily, irreversible pan-human epidermal growth factor receptor tyrosine kinase inhibitor (TKI) indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Emgality (galcanezumab-gnlm) Injection

Company: Eli Lilly and Company
Date of Approval: September 27, 2018
Treatment for: Migraine Prophylaxis

Emgality (galcanezumab-gnlm) is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.

Copiktra (duvelisib) Capsules

Company: Verastem, Inc.
Date of Approval: September 24, 2018
Treatment for: Chronic Lymphocytic Leukemia, Follicular Lymphoma

Copiktra (duvelisib) is a first-in-class, oral, dual phosphoinositide-3-kinase (PI3K)-delta/PI3K-gamma inhibitor for the treatment relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL).

Ajovy (fremanezumab-vfrm) Injection

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: September 14, 2018
Treatment for: Migraine Prophylaxis

Ajovy (fremanezumab) is a fully-humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand indicated for the preventive treatment of migraine.

Lumoxiti (moxetumomab pasudotox-tdfk) Injection

Company: AstraZeneca
Date of Approval: September 13, 2018
Treatment for: Hairy Cell Leukemia

Lumoxiti (moxetumomab pasudotox-tdfk) is an anti-CD22 recombinant immunotoxin for the treatment of adult patients with hairy cell leukemia.

Xelpros (latanoprost) Ophthalmic Emulsion

Company: Sun Pharmaceutical Industries Inc.
Date of Approval: September 12, 2018
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension

Xelpros (latanoprost) is a prostaglandin F analog indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension.

Cassipa (buprenorphine and naloxone) Sublingual Film

Company: Teva Pharmaceuticals USA, Inc.
Date of Approval: September 7, 2018
Treatment for: Opiate Dependence - Maintenance

Cassipa (buprenorphine and naloxone) sublingual film is a partial‐opioid agonist and opioid antagonist combination indicated for the maintenance treatment of opioid dependence.

Tiglutik (riluzole) Oral Suspension

Company: ITF Pharma
Date of Approval: September 5, 2018
Treatment for: Amyotrophic Lateral Sclerosis

Tiglutik (riluzole) is an easy-to-swallow, thickened, oral suspension formulation of the approved drug riluzole for the treatment of amyotrophic lateral sclerosis (ALS).

Pifeltro (doravirine) Tablets

Company: Merck
Date of Approval: August 30, 2018
Treatment for: HIV Infection

Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the combination treatment of HIV-1 infection in adults.

Jivi (antihemophilic factor [recombinant] PEGylated-aucl) Injection

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: August 30, 2018
Treatment for: Hemophilia A

Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, Factor VIII concentrate indicated to treat and control bleeding in patients with hemophilia A.

Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) Tablets

Company: Merck
Date of Approval: August 30, 2018
Treatment for: HIV Infection

Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) a nonnucleoside reverse transcriptase inhibitor [NNRTI]) and nucleoside analogue reverse transcriptase inhibitors combination indicated as a complete regimen for the treatment of HIV-1 infection in adults.

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