FDA Awards Final Approval to Entacapone Generic for Wearing-off

FDA Awards Final Approval to Entacapone Generic for Wearing-off

315801

FDA Awards Final Approval to Entacapone Generic for Wearing-off

Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of entacapone as an add-on therapy for treating end-of-dose “wearing off” in Parkinson’s disease, the company announced. These entacapone tablets are “therapeutically equivalent” to Comtan and treat the motor symptoms experienced by Parkinson’s patients when first-line therapies wear off, according to the India-based Alembic. The company had filed an Abbreviated New Drug Application (ANDA) seeking approval to…

You must be logged in to read/download the full post.