TherapeuticsMD Receives U.S. Food and Drug Administration (FDA) Approval for Supplemental New Drug Application (sNDA) for ANNOVERA®
20 May 2022 - 11:43PM
Business Wire
- ANNOVERA is the only FDA-approved
procedure-free, long-lasting, reversible birth control -
- With this approval, the Company expects a
significant reduction in its manufacturing batch rejections and an
increase in future product supply and will enable the Company to
better meet short- and long-term customer demand -
TherapeuticsMD, Inc. (NASDAQ:TXMD) (“TXMD” or the “Company”), an
innovative, leading women’s healthcare company, today announced the
FDA’s approval of a supplemental New Drug Application (sNDA) for
ANNOVERA. The sNDA included minor revisions to ANNOVERA’s in vitro
release testing specification that allowed for normal manufacturing
variability.
With the approval of the sNDA, the Company believes
approximately 7,000 additional rings will be able to enter our
supply chain and will be available to customers in the second and
third quarters of 2022. Today's sNDA approval will enable
TherapeuticsMD to better meet short- and long-term customer
demand.
“Today’s approval is an important milestone as it will allow us
to more efficiently scale, manufacture, and consistently supply
ANNOVERA to meet the increasing demand by women who want
procedure-free, long-lasting reversible birth control,” said Hugh
O’Dowd, Chief Executive Officer of TherapeuticsMD.
ANNOVERA was approved by the FDA in August 2018 as the only
long-lasting, reversible, procedure-free birth control.
Please see the Full Prescribing Information, including
indication and Boxed WARNING, for ANNOVERA (segesterone acetate and
ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading 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 therapeuticsmd.com 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: the effects of the COVID-19 pandemic; how the
proceeds from the divestiture of the company’s vitaCare business
will be utilized; the company’s ability to maintain or increase
sales of its products; the company’s ability to develop and
commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain
additional financing necessary therefor; whether the company will
be able to comply with the covenants and conditions under its term
loan facility and the company’s ability to refinance such facility;
the effects of supply chain issues on the supply of the company’s
products; the potential of adverse side effects or other safety
risks that could adversely affect the commercialization of the
company’s current or future approved products or preclude the
approval of the company’s future drug candidates; the company’s
ability to protect its intellectual property, including with
respect to the Paragraph IV notice letters the company received
regarding IMVEXXY; the length, cost and uncertain results of future
clinical trials; the company’s reliance on third parties to conduct
its manufacturing, research and development and clinical trials;
the ability of the company’s licensees to commercialize and
distribute the company’s products; the ability of the company’s
marketing contractors to market ANNOVERA; 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 impact of leadership transitions; the
volatility of the trading price of the company’s common stock and
the concentration of power in its stock ownership.
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version on businesswire.com: https://www.businesswire.com/news/home/20220520005266/en/
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
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