FDA New Drug Approvals - September 2022
Spevigo - injection, for intravenous use. Initial U.S. Approval: 9/1/2022, for the treatment of generalized pustular psoriasis flares. Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc.
Daxxify - injection, for intramuscular use. Initial U.S. Approval: 9/7/2022, for the treatment of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity. Manufactured by: Revance Therapeutics, Inc.
Rolvedon - injection, for subcutaneous use. Initial U.S. Approval: 9/9/2022, used to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Manufactured by: Spectrum Pharmaceuticals, Inc.
Sotyktu - tablets, for oral use. Initial U.S. Approval: 9/9/2022, for the treatment of moderate-to-severe plaque psoriasis. Manufactured by: Bristol-Myers Squibb Company.
Terlivaz - injection, for intravenous use. Initial U.S. Approval: 9/14/2022, used to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Manufactured by: Mallinckrodt Pharmaceuticals.
Elucirem - injection, for intravenous use. Initial U.S. Approval: 9/21/2022, used to detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body. Manufactured by: Liebel-Flarsheim Company LLC.
Omlonti - 0.002% ophthalmic solution, for topical ophthalmic use. Initial U.S. Approval: 9/22/2022, used to reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension. Manufactured by: Santen Inc.
Relyvrio - oral suspension. Initial U.S. Approval: 9/29/2022, used to treat amyotrophic lateral sclerosis (ALS). Manufactured by: Amylyx Pharmaceuticals, Inc.
Lytgobi - tablets, for oral use. Initial U.S. Approval: 9/30/2022, used to treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. Manufactured by: Taiho Pharmaceutical Co., Ltd.
FDA New Drug Approvals - October 2022
Imjudo - injection, for intravenous use. Initial U.S. Approval: 10/21/2022, used to treat unresectable hepatocellular carcinoma. Manufactured by: AstraZeneca Pharmaceuticals LP.
Tecvayli - injection, for subcutaneous use. Initial U.S. Approval:10/25/2022, used to treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy. Manufactured by: Janssen Biotech, Inc.
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