FDA Approval for VYALEV issued to ABBVIE INC

10/18/24 4:38:13 AM ET

$ABBV

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 216962
Company: ABBVIE INC

Products on NDA 216962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VYALEV	FOSCARBIDOPA AND FOSLEVODOPA	12MG/240MG / ML	INJECTION;SOLUTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2024	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf

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Former ImmunoGen CFO will join Seaport to steer capital financing strategy, accounting, FP&A and investor relations Seaport Therapeutics ("Seaport or the "Company"), a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the appointment of Lauren White as Chief Financial Officer. An accomplished biotech financial executive, Ms. White most recently served as the Chief Financial Officer at ImmunoGen (NASDAQ:IMGN) prior to its acquisition by AbbVie (NYSE:ABBV) for $10.1 billion in 2024. "I am so pleased to welcome Lauren as our CFO as we progress our clinical-stage pipeline of therapeutics for the treatme
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FDA Approval for VYALEV issued to ABBVIE INC

Products on NDA 216962

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216962

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $ABBV

$ABBV Press Releases

Fastest customizable press release news feed in the world

AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology

U.S. Food and Drug Administration Accepts for Review Allergan Aesthetics Premarket Approval Application for SKINVIVE by JUVÉDERM® for the Improvement of Neck Appearance

AbbVie to Host Second-Quarter 2025 Earnings Conference Call

$ABBV SEC Filings

SEC Form 11-K filed by AbbVie Inc.

SEC Form SD filed by AbbVie Inc.

SEC Form 10-Q filed by AbbVie Inc.

$ABBV Financials

Live finance-specific insights

AbbVie to Host Second-Quarter 2025 Earnings Conference Call

AbbVie Declares Quarterly Dividend

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AbbVie downgraded by Citigroup with a new price target

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$ABBV Insider Trading

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Director Falk Thomas J was granted 1,203 shares (SEC Form 4)

Director Freyman Thomas C was granted 1,203 shares, increasing direct ownership by 0.96% to 126,751 units (SEC Form 4)

Director Tilton Glenn F was granted 1,203 shares, increasing direct ownership by 2% to 51,564 units (SEC Form 4)

$ABBV FDA approvals

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FDA Approval for VYALEV issued to ABBVIE INC

FDA Approval for VYALEV issued to ABBVIE INC

FDA Approval for SKYRIZI issued to ABBVIE INC

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AbbVie Appoints CEO Robert A. Michael as Chairman of the Board of Directors

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Seaport Therapeutics Names Lauren White as Chief Financial Officer

$ABBV Large Ownership Changes

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SEC Form SC 13G/A filed by AbbVie Inc. (Amendment)

SEC Form SC 13G/A filed by AbbVie Inc. (Amendment)

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