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New Drug Approvals Archive - October 2017

See also: New Indications and Dosage Forms for October 2017

October 2017

Ascor (ascorbic acid) Injection

Date of Approval: October 2, 2017
Company: McGuff Pharmaceuticals, Inc.
Treatment for: Scurvy

Ascor (ascorbic acid) is an intravenous vitamin C formulation indicated for the short term treatment of scurvy.

Zilretta (triamcinolone acetonide) Sustained-Release Intra-Articular Injection

Date of Approval: October 6, 2017
Company: Flexion Therapeutics, Inc.
Treatment for: Osteoarthritis

Zilretta (triamcinolone acetonide extended-release injectable suspension) is a corticosteroid intra-articular injection indicated for the management of osteoarthritis pain of the knee.

Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion - formerly KTE-C19

Date of Approval: October 18, 2017
Company: Kite Pharma, Inc.
Treatment for: Large B-Cell Lymphoma; Follicular Lymphoma

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B cell lymphoma, and DLBCL arising from follicular lymphoma.

Shingrix (zoster vaccine recombinant, adjuvanted) Injection

Date of Approval: October 20, 2017
Company: GlaxoSmithKline
Treatment for: Herpes Zoster -- Prophylaxis

Shingrix (zoster vaccine recombinant, adjuvanted) is a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

Calquence (acalabrutinib) Capsules

Date of Approval: October 31, 2017
Company: AstraZeneca
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.

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