CLINICAL & PIPELINE·Drug Approval
AMTA Secures FDA Approval for Generic Diltiazem Hydrochloride Extended-Release Tablets, Intensifying Cardiovascular Market Competition
AMTA has secured FDA approval for its generic Diltiazem Hydrochloride extended-release tablets across six strengths, manufactured by Slate Run Pharmaceuticals. This approval, initially granted March 7, 2023, with a labeling update January 18, 2026, significantly increases competition in the cardiovascular medication market. Procurement and supply chain leaders must reassess existing contracts and explore new sourcing opportunities.
90-Day Activity
AMTADiltiazem Hydrochloride
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2026-01-18