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Posts Tagged ‘ birth control product ’

Birth Control Product Gains FDA Approval

Monday, June 1st, 2020

Exciting news!  A birth control product for use “in-the-moment,” evaluated by study participants at Coastal Connecticut Research, has gained FDA approval.  Thank you to our volunteers for participating in this women’s healthcare research study.

U.S. FDA Approves Evofem Biosciences

Phexxi TM (lactic acid, citric acid and potassium bitartrate),
the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
A New Class of Female-Controlled Birth Control for Use In-The-Moment

SAN DIEGO, May 22, 2020 — Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S.
Food and Drug Administration (FDA) has approved Phexxi  TM (lactic acid, citric acid and potassium
bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an
on-demand method of contraception.

Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain
vaginal pH within the normal range of 3.5 to 4.5 an acidic environment that is inhospitable to sperm.
There have been a limited number of advances in birth control over the last two decades.

As the first vaginal pH regulator with a unique mechanism of action, the Company is working to have
Phexxi covered under the Affordable Care Act (ACA). The ACA mandates that private health plans provide
coverage with no out-of-pocket costs for one treatment per class in each of the classes identified by the
FDA for women in its Birth Control Guide.

Evofem is committed to ensuring access to Phexxi for all women seeking non-hormonal contraception,
including for women who are not covered by government or private health plans, and will provide a
financial assistance program to enable access for eligible women.