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New Drug Approvals Archive - September 2018

See also: New Indications and Dosage Forms for September 2018

September 2018

Tiglutik (riluzole) Oral Suspension

Date of Approval: September 5, 2018
Company: ITF Pharma
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).

Cassipa (buprenorphine and naloxone) Sublingual Film

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

Marketing Status: Discontinued

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

Lumoxiti (moxetumomab pasudotox-tdfk) Injection

Date of Approval: September 13, 2018
Company: AstraZeneca and MedImmune
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

Date of Approval: September 12, 2018
Company: Sun Pharmaceutical Industries Ltd.
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.

Ajovy (fremanezumab-vfrm) Injection

Date of Approval: September 14, 2018
Company: Teva Pharmaceutical Industries Ltd.
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.

Copiktra (duvelisib) Capsules

Date of Approval: September 24, 2018
Company: Verastem, Inc.
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).

Emgality (galcanezumab-gnlm) Injection

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

Emgality (galcanezumab-gnlm) is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine, and for the treatment of episodic cluster headache.

Vizimpro (dacomitinib) Tablets

Date of Approval: September 27, 2018
Company: Pfizer Inc.
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.

Libtayo (cemiplimab-rwlc) Injection

Date of Approval: September 28, 2018
Company: Sanofi
Treatment for: Squamous Cell Carcinoma, Basal Cell Carcinoma, Non-Small Cell Lung Cancer

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC).

Arikayce (amikacin liposome) Inhalation Suspension

Date of Approval: September 28, 2018
Company: Insmed, Inc.
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.

Xyosted (testosterone enanthate) Subcutaneous Injection

Date of Approval: September 28, 2018
Company: Antares Pharma, Inc.
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.

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