FDA Approves BUPRENORPHINE AND NALOXONE — PAI Holdings, LLC dba PAI Pharma
PAI Holdings, LLC dba PAI Pharma has received FDA approval for its Abbreviated New Drug Application (ANDA 204431) for Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual tablets, completing its first generic opioid facility filing. This addition expands the generic market for this opioid combination therapy, offering increased competition and potential availability for payers and patients seeking alternative formulations.
AI-generated summary for informational purposes only. Always verify against the original filing. Not investment advice. BriefTape is not a registered investment adviser.
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