CLINICAL & PIPELINE·Drug Approval
LUPIN and SOLA Pharmaceuticals Secure Latest FDA Labeling Approval for Generic Diclofenac Sodium 1.5% Topical Solution
LUPIN, through its manufacturing partner SOLA Pharmaceuticals, has secured another FDA supplemental labeling approval for its generic Diclofenac Sodium 1.5% Topical Solution (ANDA204132) on 2024-11-21. This marks the fifth such approval since the original ANDA in 2015, underscoring continuous regulatory engagement for this key anti-inflammatory. For procurement and regulatory teams, these updates signal ongoing product lifecycle management and potential market adjustments.
90-Day Activity