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New Drug Approvals Archive - 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.

Read more: Ascor (ascorbic acid) FDA Approval History

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.

Read more: Zilretta (triamcinolone acetonide) FDA Approval History

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

Yescarta (axicabtagene ciloleucel) is a chimeric antigen receptor T cell (CAR T) therapy for the treatment of adults patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

CAR T therapy involves the engineering of a patient's T cells to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. The T cells are then redirected to kill the cancer cells. CAR T therapy is manufactured specifically for each individual patient and is considered a breakthrough in hematologic cancer treatment.

Read more: Yescarta (axicabtagene ciloleucel) FDA Approval History

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.

Read more: Shingrix (zoster vaccine recombinant, adjuvanted) FDA Approval History

Calquence (acalabrutinib) Capsules

Date of Approval: October 31, 2017
Company: AstraZeneca
Treatment for: Mantle Cell Lymphoma

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL).

Read more: Calquence (acalabrutinib) FDA Approval History

New Drug Approvals Archive