United States Food and Drug Administration (FDA) Responds to TherapeuticsMD Request to Revise Certain Manufacturing Test Limits for ANNOVERA®


BOCA RATON, Florida – (COMMERCIAL THREAD) – TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TXMD” or the “Company”), a leading innovator in women’s health, today announced that the FDA has determined that it could not approve revisions to certain manufacturing test limits for ANNOVERA through the sNDA previously submitted by the Company. In its full response letter, the FDA provided recommendations and requested additional information that may support the approval of revisions to certain manufacturing test limits. The Company will continue to manufacture and supply ANNOVERA to existing approved specifications.

The sNDA requested minor revisions to the in vitro publish test specifications for ANNOVERA to allow variation from normal commercial manufacturing. The company has submitted the proposed revisions to the manufacturing testing limits to enable it to efficiently and rapidly increase supply to meet anticipated patient demand for ANNOVERA.

“The company will continue to manufacture and supply ANNOVERA according to existing specifications and will work with the FDA to respond to their comments,” said Hugh O’Dowd, president of TherapeuticsMD.

ANNOVERA was approved by the FDA in August 2018 as the only long-lasting, reversible, non-interventional contraceptive.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative and leading healthcare company focused on the development and commercialization of new products exclusively for women. Our products are designed to respond to the unique changes and challenges women face through the various 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, please visit therapiesmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-looking statements

This TherapeuticsMD, Inc. press release may contain forward-looking statements. Forward-looking statements may include, without limitation, statements relating to the objectives, plans and strategies of TherapeuticsMD as well as statements, other than historical facts, which relate to activities, events or developments that the company has intention, expects, projects, believes or anticipates will or could occur in the future. These statements are often characterized by words such as “believes”, “hopes”, “can”, “anticipates”, “should”, “intends”, “plans”, “will”, “hopes”, “believes”. “,” Projects “,” positioned “,” strategy “and similar expressions and are based on assumptions and assessments made in light of experience and management’s 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 assumes no obligation 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 beyond the control of the Company. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections entitled “Risk Factors” in the documents filed by the Company 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: effects of the COVID-19 pandemic ; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and market IMVEXXY®, ANNOVERE®, and BIJUVA® and obtain the additional funding required for this purpose; whether the company will be able to comply with the income, minimum liquidity and other covenants and conditions under its term loan facility; whether the company will be able to successfully divest or obtain an investment in its vitaCare business and how the proceeds that may be generated by such divestiture or investment will be used; the effects of supply chain problems on the supply of the company’s products; the potential for unwanted side effects or other safety risks that could adversely affect the marketing of the Company’s current or future approved products or prevent the approval of the Company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA or revisions to the manufacturing test limits for ANNOVERA; the company’s ability to protect its intellectual property, including with respect to paragraph IV notification letters the company has received regarding IMVEXXY and BIJUVA and the corresponding regulation regarding BIJUVA; the length, cost and uncertain results of future clinical trials; the Company’s dependence 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 availability of reimbursement by government authorities and health insurance companies for company 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 shareholding structure.


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