FDA Approves Doxepin Hydrochloride Application by Sun Pharma
The FDA has approved the application ANDA213919 for Doxepin Hydrochloride submitted by Sun Pharma.
Published: July 31, 2026
Updated: July 31, 2026
Author: Humanexa Intelligence
Therapeutic area: Neurology / Antidepressant
Company: Sun Pharma
Asset: FDA
Regulatory TimelineREG
Fast Track
Breakthrough
Priority Review
PDUFA
Approval
Company
Sun Pharma
Asset
Signal assessment
Signal strength
high
Confidence level
moderate
Signalhigh
Confidencemoderate
Why it matters
The FDA's approval of Doxepin Hydrochloride by Sun Pharma is significant as it introduces a new competitor in the antidepressant market. This could shift market dynamics and necessitate strategic responses from other companies in the sector.
Recommended action
Humanexa recommends Monitor.
Analysis
Monitor market uptake and any subsequent competitive responses from other antidepressant manufacturers.
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