CLINICAL & PIPELINE·Drug Approval
BPI LABS LLC Secures Tentative FDA Approval for Generic SELENIOUS ACID Injection
BPI LABS LLC has received Tentative Approval from the FDA for its generic SELENIOUS ACID Injection (ANDA220051) in 12UG/2ML and 60UG/1ML strengths. This marks a critical regulatory milestone, positioning BPI LABS LLC for market entry upon patent expiration or exclusivity lapse of the reference product. Procurement and regulatory teams must now assess the impending competitive shift and prepare for potential new supply options.
90-Day Activity
BPI LABS LLCSelenious Acid
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2026-01-07