regulatory
confidence high
sentiment positive
materiality 0.70
Elite Pharma gets FDA nod for generic Vyvanse; $4.3B market
ELITE PHARMACEUTICALS INC /NV/
- Received FDA approval on November 15, 2024 for ANDA for generic Lisdexamfetamine Dimesylate (Vyvanse) in 7 strengths (10-70 mg capsules).
- Product indicated for ADHD; marketed under Elite Laboratories label.
- IQVIA reported annual sales of $4.3B for brand and generic market (12 months ending September 2024).