Lupin's ANDA201446 for Levonorgestrel Receives Standard Review Status
Lupin's ANDA201446 for Levonorgestrel has been submitted and is currently under standard review by the FDA.
Published: July 12, 2026
Updated: July 12, 2026
Author: Humanexa Intelligence
Therapeutic area: Women's Health / Contraceptive
Company: Lupin
Asset: Levonorgestrel
Regulatory TimelineREG
Fast Track
Breakthrough
Priority Review
PDUFA
Approval
Company
Lupin
Asset
Signal assessment
Signal strength
high
Confidence level
moderate
Signalhigh
Confidencemoderate
Why it matters
The standard review status of Lupin's ANDA201446 for Levonorgestrel is significant as it could introduce new competition in the contraceptive market. This may lead to shifts in market share among existing products, necessitating close monitoring by portfolio teams.
Recommended action
Humanexa recommends Monitor.
Analysis
Key milestones include the FDA's decision timeline and any potential responses from competitors.
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