FDA Approval for POSIMIR

2/2/21 7:24:30 AM ET

$DRRX

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 204803
Company: DURECT CORP

Products on NDA 204803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSIMIR	BUPIVACAINE	132MG/ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2021	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

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Recent Analyst Ratings for
$DRRX

Date	Price Target	Rating	Analyst

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FDA Approval for POSIMIR

2/2/21 7:24:30 AM ET

$DRRX

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $DRRX alert in real time by email

New Drug Application (NDA): 204803
Company: DURECT CORP

Products on NDA 204803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSIMIR	BUPIVACAINE	132MG/ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2021	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

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Recent Analyst Ratings for
$DRRX

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$DRRX
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DURECT Corporation Reports Second Quarter 2025 Financial Results and Provides Update on Proposed Acquisition by Bausch Health

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7/5/22 8:30:00 AM ET

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Biotechnology: Pharmaceutical Preparations

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FDA Approval for POSIMIR

Products on NDA 204803

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204803

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $DRRX

FDA Approval for POSIMIR

Products on NDA 204803

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204803

Original Approvals or Tentative Approvals

Crush Q3 2025 with the Best AI Superconnector

Recent Analyst Ratings for $DRRX

$DRRX SEC Filings

SEC Form 15-12G filed by DURECT Corporation

SEC Form EFFECT filed by DURECT Corporation

SEC Form S-8 POS filed by DURECT Corporation

$DRRX Press Releases

DURECT Corporation Reports Second Quarter 2025 Financial Results and Provides Update on Proposed Acquisition by Bausch Health

DURECT Corporation Reports First Quarter 2025 Financial Results and Provides Business Update

DURECT Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

$DRRX Insider Purchases

Large owner Asen R Scott bought $11,357 worth of shares (5,917 units at $1.92), increasing direct ownership by 0.22% to 2,672,529 units (SEC Form 4)

Large owner Asen R Scott bought $386,666 worth of shares (204,220 units at $1.89), increasing direct ownership by 5% to 2,666,612 units (SEC Form 4)

$DRRX Analyst Ratings

HC Wainwright & Co. reiterated coverage on Durect with a new price target

Chardan Capital reiterated coverage on Durect with a new price target

$DRRX Insider Trading

Amendment: SEC Form 4 filed by President & CEO Brown James E

Director Robertson Judith J. closing all direct ownership in the company (SEC Form 4)

President & CEO Brown James E returned 96,959 shares to the company, closing all direct ownership in the company (SEC Form 4)

$DRRX FDA approvals