New Drug Approvals Archive - 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
Botox Cosmetic (onabotulinumtoxinA)
New Indication Approved: October 2, 2017
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.
- Flexion Therapeutics Announces FDA Approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis Knee Pain
New Dosage Form Approved: October 12, 2017
Read more: Lyrica (pregabalin) FDA Approval History
Patient Population Altered: October 13, 2017
- Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
Read more: Stelara (ustekinumab) 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.
- FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma
New Indication Approved: October 20, 2017
- FDA Approves Simponi Aria (golimumab) for the Treatment of Adults With Active Psoriatic Arthritis or Active Ankylosing Spondylitis
Read more: Simponi (golimumab) FDA Approval History
Shingrix (zoster vaccine recombinant, adjuvanted) Injection
Date of Approval: October 20, 2017
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.
New Formulation Approved: October 20, 2017
Read more: Bydureon (exenatide) FDA Approval History
New Indication Approved: October 23, 2017
- FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (GMG)
Read more: Soliris (eculizumab) FDA Approval History
New Formulation Approved: October 25, 2017
- Tesaro Announces U.S. FDA Approval of Varubi IV for Delayed Nausea and Vomiting Associated With Cancer Chemotherapy
Read more: Varubi (rolapitant) FDA Approval History
New Dosage Regimen: October 27, 2017
- FDA Approves New 10 mg Dosing for Xarelto (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE)
Read more: Xarelto (rivaroxaban) FDA Approval History
Calquence (acalabrutinib) Capsules
Date of Approval: October 31, 2017
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).