TherapeuticsMD Receives U.S. Food and Drug Administration (FDA) Approval for Supplemental New Drug Application (sNDA) for ANNOVERA®

– ANNOVERA is the only procedure-free, durable, FDA-approved reversible contraceptive –

– With this approval, the Company expects a significant reduction in its manufacturing batch rejections and an increase in future product supply and will allow the Company to better meet customer demand in the short and long term. term –

BOCA RATON, Fla., May 20, 2022–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TXMD” or the “Company”), an innovative and leading women’s health company, today announced the approval by the FDA of a Supplemental New Drug Application (sNDA) for ANNOVERA. The sNDA included minor revisions to the ANNOVERA in vitro release test specification that allowed for normal manufacturing variability.

With sNDA approval, the company estimates that approximately 7,000 additional rings will be able to enter our supply chain and be available to customers in the second and third quarters of 2022. sNDA approval of today will enable TherapeuticsMD to better meet both short-term and long-term customer demand.

“Today’s approval is an important milestone as it will allow us to more efficiently scale, manufacture and supply ANNOVERA to meet the growing demand from women who want a no-procedure reversible contraceptive and long-lasting,” said Hugh O’Dowd, President and CEO of TherapeuticsMD.

ANNOVERA was approved by the FDA in August 2018 as the only durable, reversible, procedure-free contraceptive.

Please see 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 a leading, innovative healthcare company focused on the development and commercialization of new products exclusively for women. Our products are designed to address the unique changes and challenges women face through the different stages of their lives with a therapeutic focus on family planning, reproductive health, and menopause management. The company is committed to advancing women’s health and promoting awareness of their health issues. To learn more about TherapeuticsMD, visit therapysmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-looking statements

This press release from 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 of historical fact, that address activities, events or developments that the company intends, plans, projects, believes or predicts that it will or may occur in the future. These statements are often characterized by terms such as “believes”, “hopes”, “may”, “anticipates”, “should”, “intends”, “plans”, “will”, “expects”. to”, “estimates”, “projects”, “positioned”, “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and its perception of historical trends, current conditions, expected future developments and other factors deemed appropriate. The forward-looking statements contained in this press release are made as of the date of this press release, and the company undertakes no obligation to update or revise 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 beyond the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from the 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 sale of the company’s vitaCare business will be used; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and market IMVEXXY®, ANNOVERA® and BIJUVA® and to obtain the additional financing necessary for this purpose; whether the company will be able to meet the covenants and conditions of its term loan facility and the company’s ability to refinance such facility; the effects of supply chain issues on the Company’s product sourcing; the potential for adverse side effects or other safety risks that could adversely affect the commercialization of the Company’s current or future approved products or prevent the approval of the Company’s future drug candidates; Company’s ability to protect its intellectual property, including with respect to any Paragraph IV notice letters Company has received regarding IMVEXXY; the duration, 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 market and distribute the Company’s products; the ability of the Company’s marketing contractors to market ANNOVERA; the availability of reimbursement by governmental 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 company’s common stock price and the concentration of power in its shareholder base.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220520005266/en/

contacts

Investor Relations:

Lisa M. Wilson, On-Site Communications, Inc.
Such. : 212-452-2793
Email: [email protected]

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