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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Recent Analyst Ratings for
$ABBV

Date	Price Target	Rating	Analyst
10/17/2024	$203.00	Mkt Perform	Bernstein
6/5/2024	$185.00	Hold → Buy	HSBC Securities
5/17/2024	$200.00	Overweight	Cantor Fitzgerald
1/29/2024		Mkt Perform → Outperform	William Blair
12/18/2023		Buy → Hold	HSBC Securities
12/11/2023		Neutral → Buy	Goldman
11/9/2023	$150.00	Hold	Deutsche Bank
10/30/2023	$160.00 → $170.00	Equal Weight → Overweight	Barclays

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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

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FDA Approval for VYALEV issued to ABBVIE INC

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