How Can You Access It?

• The FDA recently approved a new generic version of the abortion pill, mifepristone.
• This approval will help make medication abortion more affordable and increase access.
• Despite political controversy surrounding medication abortion, mifepristone, generic or otherwise, is safe and effective.
• The new drug’s manufacturer expects its generic mifepristone to become available in January 2026, but insurance coverage will vary largely depending on each state’s laws.

In a significant development for reproductive healthcare access, the Food and Drug Administration (FDA) has approved a new generic version of mifepristone, a medication used in combination with misoprostol for the medical termination of pregnancy up to 70 days of gestation.

The approval, granted to Evita Solutions, LLC under Abbreviated New Drug Application (ANDA) 216616, confirms that the generic mifepristone tablets (200 milligrams) are bioequivalent and therapeutically equivalent to the brand-name product Mifeprex, manufactured by Danco Laboratories, LLC.

This decision, effective immediately, means that healthcare providers and patients will soon have access to a lower cost alternative to the branded medication, potentially expanding availability and affordability.

This approval marks a notable shift toward increasing reproductive healthcare access while maintaining comprehensive safety measures.

Since the U.S. Supreme Court’s landmark ruling that overturned Roe v. Wade in 2022, access to safe abortion has become restricted across the United States.

Kate McLean, MD, an OB-GYN and chief medical officer at Evvy, told Healthline that the FDA’s approval of a generic abortion pill is a step toward expanding access to safe, evidence-based reproductive care.

“Reproductive autonomy is foundational to women’s health, and affordability and accessibility are central to that,” she noted, adding that cost, geography, and stigma have long kept this essential care out of reach for many females.

McLean explained that the availability of a generic option makes this medication more affordable.

This is important, she said, because restrictive policies and limited options can endanger the physical and emotional health of anyone seeking an abortion.

“Expanding access through generics is not only a scientific milestone but a moral one,” she said, “reaffirming that every person deserves agency over their own body and healthcare decisions.”

McLean said, however, that access is only part of the equation.

“Stigma remains one of the biggest barriers to care,” she said. “Whether we’re talking about abortion, vaginal health, or fertility, shame and silence keep women from seeking the help they need.”

According to McLean, destigmatizing vaginal and reproductive health helps improve overall health outcomes.

“When we normalize conversations about the vaginal microbiome, sexual health, or abortion, we make it safer for women to ask questions, get care earlier, and make informed choices about their bodies,” she explained.

Charles M. Carlsen, MD, an OB-GYN and founder of Dr.Sono, emphasized that mifepristone is safe and effective when used as directed, despite political and ideological controversy surrounding it.

“The ruckus is less about the drug per se and more about the strong emotions people carry about abortion,” he said. “It involves personal values, religion, and politics, so immediately it’s a volatile issue.”

Decades of research confirm that mifepristone is safe for women to use. Other studies demonstrate that there is no meaningful difference between using a generic version of a brand-name drug.

“Currently, both … are regulated under the same safety guidelines,” said Carlsen. “Only licensed physicians and pharmacies are allowed to prescribe and distribute it.”

Carlsen further noted that there are guidelines in place that doctors follow when prescribing this medication.

“They are there for women to receive appropriate care, appropriate counseling, and appropriate follow-through,” he said. “And even with a generic, your safety filters don’t go away.”

In its letter to Evita, the FDA also emphasized that the generic will be distributed under the same strict safety protocols as the original drug.

Mifepristone is subject to a Risk Evaluation and Mitigation Strategy (REMS) program, a federally mandated system designed to ensure that the drug’s benefits outweigh its risks.

The approved REMS includes “Elements to Assure Safe Use” and requires that the program be fully operational before the product enters interstate commerce.

The mifepristone REMS program is a single, shared system among all drug manufacturers, meaning Evita Solutions’ product will join the existing safety framework, which includes provider certification, patient agreements, and controlled distribution channels to safeguard patient health.

Louise Norris, health policy analyst for healthinsurance.org, said that Evita Solutions expects its generic mifepristone to launch by January 2026.

She additionally noted that generic mifepristone has been available from another drug maker, GenBioPro, for several years.

Regarding insurance coverage, Norris said that health plans can update their formularies soon after, or they might wait until the next quarter or plan year to add the new medication.

However, “they are not obligated to add a new generic medication to their formulary, so coverage specifics for mifepristone will vary from one health plan to another,” she said.

Norris further explained that some states have laws banning its use for abortion, or they ban state-regulated health plans from covering it.

On the other hand, some states require these plans to cover abortion.

“So health coverage for abortion, including medication abortion, varies greatly by state,” she said.

Further complicating matters, mifepristone is widely used for the management of miscarriages, so it may be available and even covered by insurance for this purpose in states where abortion is illegal.

To find out whether your health plan covers mifepristone, including the newly available generic version, she said it’s first important to understand whether that coverage is limited to miscarriage management or other non-abortion care, or if it covers all approved uses.

“Once Evita Solutions’ generic mifepristone is available, consumers can follow up with their health plan to see if it’s covered and, if so, how much they’ll pay for it as part of their out-of-pocket costs,” said Norris.

The FDA’s approval of Evita Solutions’ generic mifepristone promises wider access to a safe, effective, and lower-cost option for medication abortion.

While insurance coverage and state laws vary, the generic will follow strict safety protocols under the shared REMS program.

Experts emphasize that expanding affordability and destigmatizing care are key steps in supporting reproductive health.

Consulting with your health insurance provider can help you better understand how this medication approval will affect you.