<SEC-DOCUMENT>0001387131-17-005903.txt : 20171219
<SEC-HEADER>0001387131-17-005903.hdr.sgml : 20171219
<ACCEPTANCE-DATETIME>20171219164450
ACCESSION NUMBER:		0001387131-17-005903
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20171219
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20171219
DATE AS OF CHANGE:		20171219

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			TherapeuticsMD, Inc.
		CENTRAL INDEX KEY:			0000025743
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				870233535
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-00100
		FILM NUMBER:		171264512

	BUSINESS ADDRESS:	
		STREET 1:		6800 BROKEN SOUND PARKWAY NW
		STREET 2:		THIRD FLOOR
		CITY:			BOCA RATON
		STATE:			FL
		ZIP:			33487
		BUSINESS PHONE:		561-961-1911

	MAIL ADDRESS:	
		STREET 1:		6800 BROKEN SOUND PARKWAY NW
		STREET 2:		THIRD FLOOR
		CITY:			BOCA RATON
		STATE:			FL
		ZIP:			33487

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AMHN, Inc.
		DATE OF NAME CHANGE:	20090930

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CROFF ENTERPRISES INC
		DATE OF NAME CHANGE:	19970915

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CROFF OIL CO
		DATE OF NAME CHANGE:	19920703
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>txmd-8k_121917.htm
<DESCRIPTION>CURRENT REPORT
<TEXT>
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<P STYLE="margin: 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>UNITED
STATES</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>SECURITIES
AND EXCHANGE COMMISSION</B></FONT></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-transform: uppercase; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; text-transform: none">Washington,
D.C. 20549</FONT></P>

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<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-transform: uppercase; text-align: center"></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-transform: uppercase; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif">FORM
8-K</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B>PURSUANT TO SECTION 13 OR 15(d) OF THE</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: center"><B>SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: center">Date of Report (Date of earliest event
reported): December 19, 2017</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 33%">&nbsp;</TD>
    <TD STYLE="width: 34%; border-bottom: black 1pt solid; font: 10pt Times New Roman, Times, Serif; padding-right: 5.5pt; padding-left: 5.5pt; text-align: center"><B>TherapeuticsMD, Inc.</B></TD>
    <TD STYLE="width: 33%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-right: 5.5pt; padding-left: 5.5pt; text-align: center">(Exact Name of Registrant as Specified in its Charter)</TD>
    <TD>&nbsp;</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center; text-indent: 27.5pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 32%; border-bottom: black 1pt solid; text-align: center"><B>Nevada</B></TD>
    <TD STYLE="width: 2%">&nbsp;</TD>
    <TD STYLE="width: 32%; border-bottom: black 1pt solid; text-align: center"><B>001-00100</B></TD>
    <TD STYLE="width: 2%">&nbsp;</TD>
    <TD STYLE="width: 32%; border-bottom: black 1pt solid; text-align: center"><B>87-0233535</B></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">(State or Other</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">Jurisdiction of Incorporation)</P></TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">(Commission File Number)</TD>
    <TD>&nbsp;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">(IRS Employer</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">Identification No.)</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 27.5pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 100%; border-bottom: black 1pt solid">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">6800 Broken Sound Parkway NW, Third Floor</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">Boca Raton, FL 33487</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">(Address of Principal Executive Office) (Zip Code)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center; text-indent: 27.5pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: center">Registrant's telephone number, including
area code: (561) 961-1900</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 14.3pt; text-align: justify">Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 14.3pt; text-align: justify"><FONT STYLE="font-family: Segoe UI Symbol,sans-serif">&#9744;</FONT>&nbsp;&nbsp;Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 14.3pt; text-align: justify"><FONT STYLE="font-family: Segoe UI Symbol,sans-serif">&#9744;</FONT>&nbsp;&nbsp;Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 14.3pt 14.3pt; text-align: justify; text-indent: -14.3pt"><FONT STYLE="font-family: Segoe UI Symbol,sans-serif">&#9744;</FONT>&nbsp;&nbsp;Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt 14.3pt; text-align: justify; text-indent: -14.3pt"><FONT STYLE="font-family: Segoe UI Symbol,sans-serif">&#9744;</FONT>&nbsp;&nbsp;Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&sect; 230-405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (&sect;240.12b-2 of this chapter).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt">Emerging growth company <FONT STYLE="font-size:10pt">&#9744;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt">If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. <FONT STYLE="font-size:10pt">&#9744;</FONT></P>


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<TD NOWRAP STYLE="width: 1in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Item
                                         7.01</B></FONT></TD><TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Regulation
                                         FD Disclosure.</B></FONT></TD></TR></TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0"></P>

<P STYLE="margin-top: 0; margin-bottom: 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
December 19, 2017, TherapeuticsMD, Inc., a Nevada corporation (&#8220;TherapeuticsMD&#8221; or the &#8220;Company&#8221;), issued
a press release announcing a regulatory update regarding the New Drug Application (NDA) for TX-004HR, the Company's investigational
applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse
(dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. A copy of the press release is furnished as Exhibit
99.1 to this Current Report on Form 8-K and is incorporated in this Item 7.01 by reference.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
information in Items 7.01 and 9.01 of this Current Report on Form 8-K (including the exhibit) is furnished and shall not be deemed
to be &#8220;filed&#8221; for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the &#8220;Exchange
Act&#8221;), or otherwise subject to the liabilities of that section. The information in Items 7.01 and 9.01 of this Current Report
shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether
made before or after the date of this Current Report, regardless of any general incorporation language in the filing.</FONT></P>

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<TD NOWRAP STYLE="width: 1in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Item
                                         9.01.</B></FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Financial
                                         Statements and Exhibits.</B></FONT></TD></TR></TABLE>

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<TR STYLE="vertical-align: top; text-align: left">
    <TD STYLE="width: 0.5in; text-align: right"><I>(d)</I></TD>
    <TD STYLE="width: 0.5in">&nbsp;</TD>
    <TD STYLE="width: 1in"><I>Exhibits.</I></TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>Exhibit<BR>
    <U>Number</U></TD>
    <TD STYLE="text-align: left; vertical-align: bottom"><U>Description</U></TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>99.1</TD>
    <TD><A HREF="ex99-1.htm">Press Release from TherapeuticsMD, Inc., dated December 19, 2017, entitled &#8220;TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR.&#8221;</A></TD></TR>
</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 4.3pt 0 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 10pt; text-align: center"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 10pt; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>SIGNATURES</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.</FONT></P>

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<TR STYLE="vertical-align: top">
    <TD>Date:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;December 19, 2017</TD>
    <TD COLSPAN="2">THERAPEUTICSMD, INC.</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 8%">By:</TD>
    <TD STYLE="width: 42%; border-bottom: black 1pt solid">/s/ <I>Daniel A. Cartwright</I></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>Name:</TD>
    <TD>Daniel A. Cartwright</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>Title:</TD>
    <TD>Chief Financial Officer</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center; text-indent: 27.5pt">&nbsp;</P>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex99-1.htm
<DESCRIPTION>PRESS RELEASE
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<P STYLE="margin: 0"><A HREF="txmd-8k_121917.htm">THERAPEUTICSMD, INC. 8-K</A></P>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0; text-align: right"><B>&nbsp;</B></P>

<P STYLE="margin: 0; text-align: right"><B>&nbsp;</B></P>

<P STYLE="margin: 0; text-align: left"><B></B></P>

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<TR STYLE="vertical-align: top; text-align: left">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 50%; text-align: right"><IMG SRC="ex99-1_img001.jpg" ALT="" STYLE="height: 21pt; width: 179.25pt">&nbsp;</TD></TR>
</TABLE>

<P STYLE="margin: 0; text-align: left"></P>

<P STYLE="font: 11pt/normal Calibri, Helvetica, Sans-Serif; margin: 0; text-indent: 4in"></P>

<P STYLE="font: 12pt/normal Times New Roman, Times, Serif; margin: 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>FOR
IMMEDIATE RELEASE</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>TherapeuticsMD
Announces FDA Acceptance of New Drug Application and </B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Prescription
Drug User Fee Act (PDUFA) Date for TX-004HR</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>-
</I></B><I>PDUFA target action date of May 29, 2018 <B>-</B></I></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>BOCA
RATON, Florida, Dec. 19, 2017</B> &ndash; TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women&rsquo;s healthcare company,
today announced the acceptance of the New Drug Application (NDA) resubmission for TX-004HR, the company&rsquo;s investigational
applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse
(dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause, by the U.S. Food and Drug Administration (FDA).</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA has acknowledged that the resubmission is a complete, class 2 response to the Complete Response Letter (CRL) received on May
5, 2017 for TX-004HR. The PDUFA target action date for the completion of the FDA's review is May 29, 2018.</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA has informed the Company that the additional endometrial safety information submitted to the NDA for TX-004HR on September
14, 2017 was outside of an official review cycle, thus procedurally designating a class 2 response. The Company currently plans
to launch TX-004HR in the third quarter of 2018 if approval occurs on or before the PDUFA target action date.</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&ldquo;The
acceptance of the NDA resubmission for TX-004HR is an important milestone for TherapeuticsMD and this PDUFA target action date
will allow us to maintain our timelines for launch as early as July 2018,&rdquo; said TherapeuticsMD CEO Robert G. Finizio. &ldquo;If
approved, TX-004HR has the potential to be a highly differentiated treatment option for the 32 million postmenopausal women in
the United States who suffer from symptoms of VVA.&rdquo;</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
505(b)(2) NDA resubmission for TX-004HR is supported by the complete TX-004HR clinical program, including positive results of
the phase 3 Rejoice Trial, which evaluated the effect of three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) compared to placebo
from baseline to week 12. The results demonstrated statistically significant and clinically meaningful improvements in dyspareunia,
a co-primary endpoint, and vaginal dryness, a prespecified secondary endpoint. Statistically significant results were seen as
early as two weeks of treatment. The NDA resubmission includes the 4 mcg and 10 mcg doses of TX-004HR.</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>About
TherapeuticsMD, Inc. </B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">TherapeuticsMD,
Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA&trade;
technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical
hormones through a variety of dosage forms and administration routes. The company&rsquo;s late stage clinical pipeline includes
two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR
for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy
(VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins under
the vitaMedMD&reg; and BocaGreenMD&reg; brands.</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>


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<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Forward-Looking
Statements</B></FONT></P>

<P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt/107% Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>This
press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are
not limited to, statements relating to TherapeuticsMD&rsquo;s objectives, plans and strategies as well as statements, other than
historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates
will or may occur in the future. These statements are often characterized by terminology such as &ldquo;believes,&rdquo; &ldquo;hopes,&rdquo;
&ldquo;may,&rdquo; &ldquo;anticipates,&rdquo; &ldquo;should,&rdquo; &ldquo;intends,&rdquo; &ldquo;plans,&rdquo; &ldquo;will,&rdquo;
&ldquo;expects,&rdquo; &ldquo;estimates,&rdquo; &ldquo;projects,&rdquo; &ldquo;positioned,&rdquo; &ldquo;strategy&rdquo; and similar
expressions and are based on assumptions and assessments made in light of management&rsquo;s experience and perception of historical
trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements
in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any
such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees
of future performance and are subject to risks and uncertainties, many of which are outside of the company&rsquo;s control. Important
factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements
are described in the sections titled &ldquo;Risk Factors&rdquo; in the company&rsquo;s filings with the Securities and Exchange
Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form
8-K, and include the following: the company&rsquo;s ability to resolve the deficiencies identified by the FDA in the company&rsquo;s
new drug application for its TX-004HR product candidate and the time frame associated with such resolution; whether the FDA will
approve the company&rsquo;s resubmitted NDA for its TX-004HR product candidate; the company&rsquo;s ability to maintain or increase
sales of its products; the company&rsquo;s ability to develop and commercialize its hormone therapy drug candidates and obtain
additional financing necessary therefor; whether the company will be able to prepare an NDA for its TX-001HR product candidate
and, if prepared, whether the FDA will accept and approve the NDA; the length, cost and uncertain results of the company&rsquo;s
clinical trials, including any additional clinical trials that the FDA may require in connection with TX-004HR; the potential
of adverse side effects or other safety risks that could preclude the approval of the company&rsquo;s hormone therapy drug candidates;
the company&rsquo;s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the
availability of reimbursement from government authorities and health insurance companies for the company&rsquo;s products; the
impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading
price of the company&rsquo;s common stock and the concentration of power in its stock ownership. PDF copies of the company&rsquo;s
historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.</I></FONT></P>

<P STYLE="font: 10pt/107% Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">#
# #</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 5.35pt; text-indent: -5.35pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><U>Investor
Contact</U></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 292.5pt 0 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 292.3pt 0 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">David
DeLucia</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 292.3pt 0 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director,
Investor Relations</FONT></P>

<P STYLE="font: 10pt/107% Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">561-961-1900<BR>
David.DeLucia@TherapeuticsMD.com</FONT></P>

<P STYLE="font: 12pt/normal Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>



<P STYLE="margin: 0; text-align: left"></P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
