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
5/14/2025	$205.00	Buy → Neutral	Citigroup
4/22/2025	$210.00	Overweight	Cantor Fitzgerald
12/10/2024	$191.00	Neutral	BofA Securities
12/5/2024	$180.00	Outperform → Neutral	Daiwa Securities
11/22/2024	$206.00	Market Perform → Outperform	Leerink Partners
11/15/2024	$205.00	Outperform	Wolfe Research
11/4/2024		Hold → Buy	Argus
10/17/2024	$203.00	Mkt Perform	Bernstein

More analyst ratings

FDA Approval for VYALEV issued to ABBVIE INC

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

$ABBV

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $ABBV alert in real time by email

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
5/14/2025	$205.00	Buy → Neutral	Citigroup
4/22/2025	$210.00	Overweight	Cantor Fitzgerald
12/10/2024	$191.00	Neutral	BofA Securities
12/5/2024	$180.00	Outperform → Neutral	Daiwa Securities
11/22/2024	$206.00	Market Perform → Outperform	Leerink Partners
11/15/2024	$205.00	Outperform	Wolfe Research
11/4/2024		Hold → Buy	Argus
10/17/2024	$203.00	Mkt Perform	Bernstein

More analyst ratings

$ABBV
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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

Crush Q3 2025 with the Best AI Executive Assistant

Recent Analyst Ratings for $ABBV

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

Crush Q3 2025 with the Best AI Executive Assistant

Recent Analyst Ratings for $ABBV

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