Elite Pharmaceuticals Inc (ELTP)

[ARbigguy1]

Opiate analgesics next? $720 million So based on info provided by Winechemist's excellent guidance GUDUFA target date assigned, from his experience this is running 9-12 months out. We know Elite filed an Abbreviated New Drug Application (ANDA) on August 17, 2023, and was accepted for review by the US Food and Drug Administration (FDA) on September 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics. IQVIA reported annual sales for the twelve months ending June 2023 of $720 million for the brand and generic market for this product.
FDA approval could come as soon as JUNE/JULY this summer.... or later OCT/NOV but we are seeing that ELITE has a pattern of getting approvals.
Just gets better and better and will go higher and higher!!!