Original New Drug Application Approvals by US FDA (01-15 August 2021)

New drug applications approved by US FDA as of 01-15 August 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

NEXVIAZYME

• Active Ingredient(s): Avalglucosidase Alfa-ngpt
• Strength: 100MG
• Dosage Form(s) / Route(s): Injectable; Injection
• Company: Genzyme Corp
• Approval Date: 06 August 2021
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency).
• Approved Label: 06 August 2021 (PDF)

WELIREG

• Active Ingredient(s): Belzutifan
• Strength: 40MG
• Dosage Form(s) / Route(s): Tablet; Oral
• Company: Merck Sharp Dohme
• Approval Date: 13 August 2021
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.
• Approved Label: 13 August 2021 (PDF)