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New Drug Approvals Archive - February 2019

See also: New Indications and Dosage Forms for February 2019

February 2019

Jeuveau (prabotulinumtoxinA-xvfs) Injection

Date of Approval: February 1, 2019
Company: Evolus, Inc.
Treatment for: Glabellar Lines

Jeuveau (prabotulinumtoxinA) is a proprietary 900 kDa purified botulinum toxin type A formulation for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines.

Cablivi (caplacizumab-yhdp) Injection

Date of Approval: February 6, 2019
Company: Ablynx NV
Treatment for: Acquired Thrombotic Thrombocytopenic Purpura

Cablivi (caplacizumab-yhdp) is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Egaten (triclabendazole) Tablets

Date of Approval: February 13, 2019
Company: Novartis
Treatment for: Fascioliasis

Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.

Esperoct (turoctocog alfa pegol) Injection

Date of Approval: February 19, 2019
Company: Novo Nordisk
Treatment for: Hemophilia A

Esperoct (turoctocog alfa pegol, N8-GP) is an extended half-life factor VIII molecule for the treatment of adults and children with hemophilia A.

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for Subcutaneous Injection

Date of Approval: February 28, 2019
Company: Genentech, Inc.
Treatment for: Breast Cancer

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is a combination of the approved HER2/neu receptor antagonist trastuzumab (Herceptin) and recombinant human hyaluronidase PH20 (an enzyme that helps to deliver trastuzumab under the skin) indicated for the treatment of HER2-overexpressing breast cancer.

Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules

Date of Approval: February 27, 2019
Company: Adlon Therapeutics L.P.
Treatment for: Attention-Deficit / Hyperactivity Disorder

Adhansia XR (methylphenidate hydrochloride) is an extended-release capsule formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older.

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