FDA Approval for IMVEXXY issued to THERAPEUTICSMD INC

11/17/21 4:38:32 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

New Drug Application (NDA): 208564
Company: THERAPEUTICSMD INC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMVEXXY	ESTRADIOL	0.004MG	INSERT;VAGINAL	Prescription	None	Yes	No
IMVEXXY	ESTRADIOL	0.01MG	INSERT;VAGINAL	Prescription	None	Yes	Yes

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208564s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208564Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208564Orig1s000TOC.cfm

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208564s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208564Orig1s003ltr.pdf
11/16/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208564s003lbl.pdf
05/29/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208564s000lbl.pdf

Date	Price Target	Rating	Analyst
3/11/2022	$3.00 → $2.50	Buy	HC Wainwright & Co.
11/12/2021	$4.00 → $3.00	Buy	HC Wainwright & Co.

Recent Analyst Ratings for
$TXMD