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New Drug Approvals Archive - December 2018

See also: New Indications and Dosage Forms for December 2018

December 2018

Elepsia XR (levetiracetam) Extended-Release Tablets

Date of Approval: December 20, 2018
Company: Sun Pharma Global
Treatment for: Epilepsy

Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures.

Elepsia XR (levetiracetam) Extended-Release Tablets

Date of Approval: December 20, 2018
Company: Sun Pharma Global
Treatment for: Epilepsy

Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures.

Tolsura (itraconazole) Capsules

Date of Approval: December 11, 2018
Company: Mayne Pharma
Treatment for: Blastomycosis; Histoplasmosis; Aspergillosis

Tolsura (itraconazole) is an azole antifungal indicated for the treatment of certain fungal infections including blastomycosis, histoplasmosis and aspergillosis.

Herzuma (trastuzumab-pkrb) for Injection

Date of Approval: December 14, 2018
Company: Celltrion, Inc. and Teva Pharmaceutical Industries Ltd.
Treatment for: Breast Cancer

Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer.

Motegrity (prucalopride) Tablets

Date of Approval: December 14, 2018
Company: Shire plc
Treatment for: Chronic Idiopathic Constipation

Motegrity (prucalopride) is a selective serotonin type 4 (5‑HT4) receptor agonist for the treatment of chronic idiopathic constipation (CIC) in adults.

Asparlas (calaspargase pegol-mknl) Injection

Date of Approval: December 20, 2018
Company: Servier Pharmaceuticals LLC
Treatment for: Acute Lymphoblastic Leukemia

Asparlas (calaspargase pegol-mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia.

Ultomiris (ravulizumab-cwvz) Injection

Date of Approval: December 21, 2018
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Elzonris (tagraxofusp-erzs) Injection

Date of Approval: December 21, 2018
Company: Stemline Therapeutics, Inc.
Treatment for: Blastic Plasmacytoid Dendritic Cell Neoplasm

Elzonris (tagraxofusp-erzs) is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Inbrija (levodopa) Inhalation Powder

Date of Approval: December 21, 2018
Company: Acorda Therapeutics, Inc.
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

ProAir Digihaler (albuterol sulfate) Inhalation Powder

Date of Approval: December 21, 2018
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Bronchospasm Prophylaxis, Asthma, Chronic Obstructive Pulmonary Disease

ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm.

Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) Suspension for Intramuscular Injection

Date of Approval: December 21, 2018
Company: Merck and Sanofi
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prophylaxis, Haemophilus influenzae Prophylaxis

Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday).

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