Special Advisory: Indies Pharma Jamaica Limited (INDIES)
Michael Phang2024-09-06T16:13:05-05:00September 6, 2023 Indies Pharma Jamaica Limited (INDIES) has announced that the U.S. Food and Drug Administration has approved its abbreviated new drug application (ANDA). This approval concerns the Regadenoson Injection, 0.4 mg/5 mL, an application which was submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FE&C Act).