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New Drug Approvals Archive - November 2018

See also: New Indications and Dosage Forms for November 2018

November 2018

Sympazan (clobazam) Oral Film

Date of Approval: November 1, 2018
Company: Aquestive Therapeutics, Inc.
Treatment for: Lennox-Gastaut Syndrome

Sympazan (clobazam) is an oral film benzodiazepine formulation indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

Dsuvia (sufentanil) Sublingual Tablets

Date of Approval: November 2, 2018
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

Dsuvia (sufentanil) is a synthetic opioid analgesic formulation for the management of acute pain that is severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.

Lorbrena (lorlatinib) Tablets

Date of Approval: November 2, 2018
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer

Lorbrena (lorlatinib) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC).

Udenyca (pegfilgrastim-cbqv) Injection

Date of Approval: November 2, 2018
Company: Coherus BioSciences, Inc.
Treatment for: Neutropenia Associated with Chemotherapy

Udenyca (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy.

Bryhali (halobetasol propionate) Lotion - formerly Jemdel

Date of Approval: November 6, 2018
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults.

Primatene Mist (epinephrine) Inhalation Aerosol

Date of Approval: November 8, 2018
Company: Amphastar Pharmaceuticals, Inc.
Treatment for: Asthma

Primatene Mist (epinephrine) is an over-the-counter (OTC) bronchodilator used for the temporary relief of the symptoms of mild asthma. The new formulation of Primatene Mist approved November 2018 is a CFC-free metered dose inhaler (MDI) containing hydrofluoroalkane (HFA) propellants.

Yupelri (revefenacin) Inhalation Solution

Date of Approval: November 9, 2018
Company: Theravance Biopharma, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

Yupelri (revefenacin) is a long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD).

Aemcolo (rifamycin) Delayed-Release Tablets

Date of Approval: November 16, 2018
Company: Cosmo Technologies, Ltd.
Treatment for: Traveler's Diarrhea

Aemcolo (rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli.

Gamifant (emapalumab-lzsg) Injection

Date of Approval: November 20, 2018
Company: Novimmune SA
Treatment for: Hemophagocytic Lymphohistiocytosis

Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking antibody for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH).

Daurismo (glasdegib) Tablets

Date of Approval: November 21, 2018
Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Daurismo (glasdegib) is a hedgehog pathway inhibitor indicated for the combination treatment of adult patients ≥75 years with newly-diagnosed acute myeloid leukemia (AML).

Vitrakvi (larotrectinib) Capsules and Oral Solution

Date of Approval: November 26, 2018
Company: Loxo Oncology, Inc.
Treatment for: TRK Fusion Cancers

Vitrakvi (larotrectinib) is an oral selective tropomyosin receptor kinase (TRK) inhibitor for the treatment solid tumors harboring NTRK-fusion proteins.

Truxima (rituximab-abbs) Injection

Date of Approval: November 28, 2018
Company: Celltrion, Inc.
Treatment for: non-Hodgkin's Lymphoma

Truxima (rituximab-abbs) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma.

Xospata (gilteritinib) Tablets

Date of Approval: November 28, 2018
Company: Astellas Pharma Inc.
Treatment for: Acute Myeloid Leukemia

Xospata (gilteritinib) is a FLT3/AXL kinase inhibitor indicated for the treatment of patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Firdapse (amifampridine phosphate) Tablets

Date of Approval: November 28, 2018
Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Lambert Eaton Myasthenic Syndrome

Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in adults.

Dextenza (dexamethasone) Ophthalmic Insert

Date of Approval: November 30, 2018
Company: Ocular Therapeutix, Inc.
Treatment for: Post-Surgical Ocular Inflammation and Pain

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain.

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