Elite Pharmaceuticals Inc (ELTP)

[ARbigguy1]

Series of Elite approvals coming soon.
They have an undisclosed generic, generic Percocet, and Hydrocodone and Acetaminophen Combo.
GDUFA goal of eliminating backlog and speeding up approval has been steadily improving. Approximately 10 months now.

Link: https://www.americanactionforum.org/research/primer-generic-drug-approval-backlog/

The goal of GDUFA was to eliminate the ANDA backlog and reduce the average review time to ten months or less. The program has so far shown signs of success, action has been taken on 84 percent of the backlog, reducing it from 2,414 to just under 400 ANDAs, and newly submitted ANDAs will likely have average review periods of close to ten months.
GDUFA does prioritize some drugs over others, which may increase the anticipated review periods for certain classes of drugs. Generics that address ‘medical shortages’ may be fast-tracked. Likewise, where there is a lack of competition in the market (with only one manufacturer of a drug), first-entrant generics are also fast-tracked.