- The U.S. Food and Drug Administration (FDA) accepted for review Amneal Pharmaceuticals ( NYSE: AMRX ) application seeking approval of a generic version of opioid overdose therapy Narcan.
- Amneal had filed Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg.
- "We are well prepared to launch this product at a significant scale and substantially increase access to this life-saving medicine as we work to help combat this endemic crisis," said Andy Boyer, chief commercial officer, Amneal Generics.
- Separately, the company also reported Q4 results which saw adjusted EPS and revenue beat analysts estimates.
- AMRX +14.35% to $2.39 premarket March 2
For further details see:
Amneal stock rises ~15% on FDA review of Narcan generic, Q4 beat