FDA Grants AP Status to Epic Pharma's Leucovorin Calcium Supplement
The FDA has granted approval status (AP) for Epic Pharma's ANDA074544 for Leucovorin Calcium.
Published: July 12, 2026
Updated: July 12, 2026
Author: Humanexa Intelligence
Therapeutic area: Oncology / Supportive Care
Company: Epic Pharma
Asset: FDA
Regulatory TimelineREG
Fast Track
Breakthrough
Priority Review
PDUFA
Approval
Company
Epic Pharma
Asset
Signal assessment
Signal strength
high
Confidence level
moderate
Signalhigh
Confidencemoderate
Why it matters
The FDA's approval status for Epic Pharma's Leucovorin Calcium enhances their competitive position in the oncology supportive care market. This could influence market dynamics, pricing strategies, and market share for similar products.
Recommended action
Humanexa recommends Monitor.
Analysis
Monitor for final approval and market entry timelines for Leucovorin Calcium.
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