TherapeuticsMD, Inc. (NYSEMKT:TXMD) Files An 8-K Other Events

Item 8.01.

On July 7, 2016, TherapeuticsMD, Inc., a Nevada corporation (the
Company), submitted to the U.S. Food and Drug
Administration (the FDA) a New Drug Application (the
NDA) under Section 505(b)(2) of the Federal Food, Drug,
and Cosmetic Act for three doses of TX-004HR, the Companys
applicator-free vaginal estradiol softgel drug candidate for the
treatment of moderate to severe dyspareunia (vaginal pain during
sexual intercourse), a symptom of vulvar and vaginal atrophy
(VVA), in post-menopausal women. The submission was accepted by
the FDA and the FDA set a target action date under the
Prescription Drug User Fee Act (PDUFA) of May 7, 2017 to
complete the FDAs review of the NDA. In a letter dated September
19, 2016, the FDA notified the Company of the FDAs target date of
April 9, 2017 for communicating to the Company proposed labeling
and/or postmarketing requirements/commitments in accordance with
FDAs PDUFA Reauthorization Performance Goals And Procedures
Fiscal Years 2013 Through 2017.

On April 7, 2017, the Company received a letter from the FDA (the
Letter) stating that, as part of its ongoing review of the
NDA, the FDA has identified deficiencies that preclude discussion
of labeling and postmarketing requirements/commitments at this
time. The Letter states that it does not reflect a final decision
on the information under review. The Letter does not specify the
deficiencies identified by the FDA and at this time the Company
is not aware of the nature of the deficiencies. The Company
intends to work with the FDA to understand the nature of the
deficiencies and resolve them as quickly as possible.

On April 10, the Company issued a press release (the Press
Release) announcing its receipt of the Letter. Copies of the
Press Release and the Letter are attached hereto as Exhibits 99.1
and 99.2, respectively, and are incorporated herein by reference.

By filing this Current Report on Form 8-K, the Company makes no
admission as to the materiality of any information contained
herein. The information contained in this report is intended to
be considered in the context of the Companys filings with the
U.S. Securities and Exchange Commission (the Commission)
and other public announcements that the Company makes, by press
release or otherwise, from time to time. The Company undertakes
no duty or obligation to publicly update or revise the
information contained in this report, except as required by law,
although it may do so from time to time as it believes is
appropriate. Any such updating may be made through the filing of
other reports or documents with the Commission, through press
releases or through other public disclosure.

This report contains forward-looking statements. Forward-looking
statements may include, but are not limited to, statements
relating to the Companys 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 the Companys managements 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 Companys 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 Companys filings with the Commission,
including its most recent Annual Report on Form 10-K for the year
ended December 31, 2016, and include the following: the Companys
ability to resolve the deficiencies identified by the FDA in the
Companys NDA for its TX-004HR product candidate; whether the FDA
will approve the Companys new drug application for its TX-004HR
product candidate and whether any such approval will occur by the
PDUFA date; the Companys ability to maintain or increase sales of
its products; the Companys 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 Companys clinical
trials; the potential of adverse side effects or other safety
risks that could preclude the approval of the Companys hormone
therapy drug candidates; the Companys 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 Companys
products; the impact of product liability lawsuits; the influence
of extensive and costly government regulation; the volatility of
the trading price of the Companys common stock and the
concentration of power in its stock ownership.

About TherapeuticsMD, Inc. (NYSEMKT:TXMD)

TherapeuticsMD, Inc. is a women’s healthcare company engaged in creating and commercializing products for women. The Company is focused on pursuing regulatory approvals and pre-commercialization activities necessary for commercialization of its hormone therapy pharmaceutical products. Its drug candidates used in clinical trials are designed to alleviate symptoms of and reduce health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis and vaginal discomfort. With its SYMBODA technology, it is developing hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through dosage forms and administration routes. Its product line includes vitaTrue, vitaPearl, vitaMedMD Plus, vitaMedMD One Prenatal Multivitamin, vitaMedMD Plus Rx Prenatal Multivitamin, vitaMedMD One Rx Prenatal Multivitamin, vitaMedMD Iron 21/7, vitaMedMD Vitamin D3 50,000 IU, BocaGreenMD Prena1 Pearl and BocaGreenMD Prena1 Chew.

TherapeuticsMD, Inc. (NYSEMKT:TXMD) Recent Trading Information

TherapeuticsMD, Inc. (NYSEMKT:TXMD) closed its last trading session down -0.39 at 7.70 with 2,815,053 shares trading hands.