TherapeuticsMD Enters Into Label Discussions for TX-001HR

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare
company, today announced that the Company has entered into discussions
with the U.S. Food and Drug Administration (FDA) regarding the proposed
label for TX-001HR, the Company’s investigational bio-identical hormone
therapy combination of estradiol and progesterone in a single, oral
softgel for the treatment of moderate-to-severe vasomotor symptoms due
to menopause. As previously announced, the Prescription Drug User Fee
Act (PDUFA) target action date for the completion of the FDA’s review of
the new drug application (NDA) for TX-001HR is October 28, 2018. The
Company does not anticipate providing subsequent updates with respect to
label discussions prior to the PDUFA target action date. There can be no
assurance that the FDA will approve the NDA for TX-001HR, or that such
approval will occur by the PDUFA target action date, and the entrance
into label discussions does not imply otherwise.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on
developing and commercializing novel products exclusively for women. Our
products are designed to address the unique changes and challenges women
experience through the various stages of their lives with a therapeutic
focus in family planning, reproductive health, and menopause management.
The company is committed to advancing the health of women and
championing awareness of their healthcare issues. To learn more about
TherapeuticsMD, please visit
or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-Looking Statements

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’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
“believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,”
“will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and
similar expressions and are based on assumptions and assessments made in
light of management’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’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 “Risk Factors” in the
company’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: whether
the FDA will approve the NDA for the company’s TX-001HR product
candidate and whether such approval will occur by the PDUFA target
action date; the company’s ability to maintain or increase sales of its
products; the company’s ability to develop and commercialize IMVEXXYTM,
ANNOVERA and its hormone therapy drug candidates and obtain additional
financing necessary therefor; whether the company will be able to comply
with the covenants and conditions under its term loan agreement; the
length, cost and uncertain results of the company’s clinical trials; the
potential of adverse side effects or other safety risks that could
preclude the approval of the company’s hormone therapy drug candidates
or adversely affect the commercialization of the company’s current or
future approved products; the company’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’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’s common
stock and the concentration of power in its stock ownership. PDF copies
of the company’s historical press releases and financial tables can be
viewed and downloaded at its website:


TherapeuticsMD, Inc.
Investor Contact:
Nichol Ochsner,
561-961-1900, Ext. 2088
Vice President Investor Relations