Market Newsdesk

Organon Announces US Food and Drug Administration Approval of Supplemental New Drug Application Extending Duration of Use of NEXPLANON^® (etonogestrel implant) 68 mg Radiopaque

JERSEY CITY, N.J.–(BUSINESS WIRE)–
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON^® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of NEXPLANON for up to five years, an extension of the previous three-year indication. During the clinical trial to assess the contraceptive efficacy and safety of extended use (years 4 and 5), no pregnancies were reported and there were no new safety findings.¹ Additionally, the study enrolled women with a range of body mass index (BMI) values (17.2 to 64.3 kg/m²), with 38.1% of them having a BMI ≥30 kg/m².

“Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s women’s health franchise,” said Organon’s Head of Research and Development and Chief Medical Officer, Juan Camilo Arjona Ferreira, MD. “The sNDA approval of an extended duration up to five years, along with data about the use of NEXPLANON in women with varying BMIs, including women with overweight or obesity, is a testament to Organon’s commitment to inclusive and comprehensive women’s healthcare.”

In addition, this approval includes a new Risk Evaluation and Mitigation Strategy (REMS) program in the US to mitigate complications due to improper insertion and removal.² This REMS program will enhance Organon’s existing Clinical Training Program (CTP) and controlled distribution program, which has been in place since 2006, by instituting important proactive measures to certify providers in the proper insertion and removal of our product. See additional safety information below.

“The updated label for NEXPLANON reflects the diversity of patients we see every day—women throughout their reproductive ages, those seeking a long-acting option of up to five years, those who prefer birth control that goes in the arm rather than the uterus, and women across a wide range of BMIs,” said Anita Nelson, MD, Professor, Obstetrics and Gynecology at Western University of Health Sciences. “The REMS program builds on existing training requirements to ensure providers maintain the highest standards for insertion and removal, reinforcing confidence and best clinical practice.”

About the Extended-Use Trial for NEXPLANON

The contraceptive efficacy of NEXPLANON during use from 3 to 5 years was evaluated in a multicenter, single-arm, open-label study (NCT04626596) conducted in the United States.¹ A total of 399 women were evaluated, having a mean age of 27 years, ranging from 18 to 35 years, and having been using NEXPLANON for 36 months (± 2 weeks) from the date of insertion at the time of enrollment. Participants were 74.2% White, 16.8% Black/African American, 3.8% Asian, 1.3% American Indian or Alaska Native, 0.5% Native Hawaiian or Other Pacific Islander, and 3.5% multiple or missing races. The mean BMI was 29.4 kg/m² (range: 17.2-64.3 kg/m²), and the mean weight was 78.7 kg (range: 40.8-180.8 kg). One hundred fifty-two participants (38.1%) had a BMI ≥30 kg/m², including 40 participants (10.0%) with a BMI ≥40 kg/m².

The primary efficacy endpoint was the Pearl Index (PI) at years 4 and 5. No pregnancies were reported during this period, resulting in a PI of 0.0 (95% CI: 0.00, 0.69) pregnancies per 100 women-years of use, and there were no new safety findings.¹

About NEXPLANON REMS

A REMS is a strategy used by the FDA to manage known or potential risks associated with a product.² To mitigate complications due to improper insertion and removal, the FDA is requiring the implementation of a REMS program for NEXPLANON. NEXPLANON will only be available in the US through the NEXPLANON REMS program, which is planned to be available starting on February 23, 2026. Providers will have six months to enroll in the program in order to maintain their access to NEXPLANON for insertion.

If providers have questions, they can contact their Organon representative. They can also visit www.NEXPLANONREMS.com or call the Organon Service Center at 1-844-674-3200. If patients have questions, they should contact their healthcare provider.

Indication

NEXPLANON^® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.

Selected Safety Information

WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL

Improper insertion of NEXPLANON increases the risk of complications.

Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion.

Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS.

CONTRAINDICATIONS

• NEXPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal uterine bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past; and/or allergic reaction to any of the components of NEXPLANON.

WARNINGS and PRECAUTIONS

Risk of Complications Due to Improper Insertion and Removal

Complications of Insertion and Removal

• NEXPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert NEXPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

• Complications related to insertion and removal procedures may occur, e.g., pain, paresthesia, bleeding, hematoma, scarring, or infection. If NEXPLANON is inserted deeply (intramuscular or intrafascial), neural or vascular injury may occur.

• Postmarketing reports of implants located within the vessels of the arm and the pulmonary artery may have been related to deep insertions or intravascular insertions. Endovascular or surgical procedures may be needed for removal.

• Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. If at any time the implant cannot be palpated, it should be localized, and removal is recommended. When an implant is removed, it is important to remove it in its entirety. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

Broken or Bent Implants

• Cases of breakage or bending of implants while inserted within a patient’s arm have been reported. Cases of migration of a broken implant fragment within the arm have also occurred. These cases may be related to external forces, e.g., manipulation of the implant or contact sports. The release rate of etonogestrel may be slightly increased in a broken or bent implant, based on in vitro data.

NEXPLANON is available only through a restricted program under a REMS.

NEXPLANON REMS

• NEXPLANON is only available through a restricted program under a REMS called NEXPLANON REMS because of the risk of complications due to improper insertion and removal.

Notable requirements of the NEXPLANON REMS include the following:

• Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion and removal of NEXPLANON prior to first use.

• Pharmacies must be certified with the program and must only dispense NEXPLANON to certified healthcare providers who dispense NEXPLANON for insertion.

• Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers.

Further information is available at www.NEXPLANONREMS.com and 1-833-697-7367.

Changes in Menstrual Bleeding Patterns

• After starting NEXPLANON, women are likely to have changes in their menstrual bleeding pattern. These may include changes in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Women should be counseled regarding bleeding pattern changes that they may experience.

Ectopic Pregnancies

• Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain.

Thrombotic and Other Vascular Events

• The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.

Ovarian Cysts

• If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Rarely, surgery may be required.

Carcinoma of the Breast and Reproductive Organs

• Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer and increase the risk of cervical cancer or intraepithelial neoplasia. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.

Liver Disease

• NEXPLANON should be removed if jaundice occurs.

Elevated Blood Pressure

• The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled.

Gallbladder Disease

• Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like NEXPLANON.

Carbohydrate and Lipid Metabolic Effects

• Prediabetic and diabetic women using NEXPLANON should be carefully monitored.

Depressed Mood

• Women with a history of depressed mood should be carefully observed. Consideration should be given to removing NEXPLANON in patients who become significantly depressed.

Return to Ovulation

• In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

Fluid Retention

• Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if NEXPLANON causes fluid retention.

Contact Lenses

• Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

ADVERSE REACTIONS

Clinical Trial Experience

• The most common adverse reaction causing discontinuation of use of the implant in 3-year clinical trials was change in menstrual bleeding patterns (11.1%).The most common adverse reactions (≥5%) reported in these clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%). In a separate clinical trial to assess contraceptive efficacy and safety of NEXPLANON beyond 3 years, up to 5 years, a similar adverse reaction profile was observed as in Years 1 through 3. The most frequently reported adverse reaction >5% was intermenstrual bleeding (5.4%). Changes in menstrual bleeding patterns were the most frequently reported adverse reaction leading to discontinuation occurring in 4.0% of participants.

DRUG INTERACTIONS

Effects of Other Drugs on Hormonal Contraceptives

Substances decreasing the plasma concentrations of hormonal contraceptives and potentially diminishing the efficacy of hormonal contraceptives:

• Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of hormonal contraceptives and potentially diminish the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Women should use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with hormonal contraceptives, and continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of hormonal contraceptives:

• Co-administration of certain hormonal contraceptives and strong or moderate CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel.

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

• Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors, HCV protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. These changes may be clinically relevant.

Effects of Hormonal Contraceptives on Other Drugs

• Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

USE IN SPECIFIC POPULATIONS

Pregnancy

• Rule out pregnancy before inserting NEXPLANON.

Lactation

• Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants.

• Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.

Pediatric Use

• The safety and effectiveness of NEXPLANON have been established in women of reproductive potential. Safety and effectiveness of NEXPLANON are expected to be the same in postpubertal adolescents as in adult women. NEXPLANON is not indicated before menarche.

PATIENT COUNSELING INFORMATION

• Advise women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant.

• NEXPLANON does not protect against HIV or other STDs.

Before prescribing NEXPLANON, please read the Prescribing Information, including the Boxed Warning. The Patient Information also is available.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations for the market potential for the five-year indication for NEXPLANON. Forward-looking statements may be identified by words such as “continue,” “forward,” “seek,” “strategy,” “commitment,” “mission,” “expect,” “future,” “believes,” “will,” “potential,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to grow the market for NEXPLANON as expected; expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the US or other governments; changes in US and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and health care reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; an inability to fully execute on Organon’s product development and commercialization plans; manufacturing difficulties or delays; disruptions at the US Food and Drug Administration, the US Securities and Exchange Commission (the “SEC”) and other US and comparable foreign government agencies; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to Organon’s marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov).

________________

¹ Data available on request from Organon Professional Services-DAP (Marketing Operations), 30 Hudson St., Jersey City, NJ 07302. Please specify information package US-XPL-117854.

² Risk evaluation and mitigation strategies | REMS. US Food and Drug Administration. Updated May 20, 2025. Accessed September 10, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

View source version on businesswire.com: https://www.businesswire.com/news/home/20260116204496/en/

Media Contacts:

Janine Colavita

(732) 861-3806

Kate Vossen

(732) 675-8448

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Renee McKnight

(551) 204-6129

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Family Health FDA Medical Devices Consumer Women Pharmaceutical

MEDIA:

Logo

New Era Energy & Digital Closes Acquisition of Remaining 50% of TCDC from Sharon AI

MIDLAND, Texas–(BUSINESS WIRE)–
New Era Energy & Digital, Inc. (Nasdaq: NUAI) (“New Era” or the “Company”), a developer and operator of next-generation digital infrastructure and integrated power assets in the Permian Basin, today announced that it completed its acquisition of Sharon AI’s (OTC: SHAZ) 50% ownership interest in Texas Critical Data Centers LLC (“TCDC”), previously announced on Dec. 23, 2025 (read here.) Sharon AI will have no continuing ownership interest, governance rights, or control provisions with respect to the project.

E. Will Gray II, CEO of New Era Energy & Digital, commented: “We appreciate the support of Sharon AI throughout the development phase of TCDC. Their partnership helped us move the project forward, and we are grateful for their collaboration. This buy-out agreement reflects a constructive outcome for both parties and positions TCDC for its next stage of development as we shift from planning to execution.”

Advisors

Vinson & Elkins L.L.P. served as legal counsel to New Era. Sheppard, Mullin, Richter & Hampton LLP served as legal counsel to Sharon AI.

About New Era Energy & Digital, Inc.

New Era Energy & Digital, Inc. (Nasdaq: NUAI) is a developer and operator of next-generation digital infrastructure and integrated power assets. With a growing portfolio of strategically located, vertically integrated resources including powered land and powered shells, the Company delivers turnkey solutions that enable hyperscale, enterprise, and edge operators to accelerate data center deployment, optimize total cost of ownership, and future-proof its infrastructure investments. For more information, visit: www.newerainfra.ai, and follow New Era Energy & Digital on LinkedIn and X.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements.” Forward-looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation: (a) our ability to effectively operate our business segments; (b) our ability to manage our research, development, expansion, growth and operating expenses; (c) our ability to evaluate and measure our business, prospects and performance metrics; (d) our ability to compete, directly and indirectly, and succeed in a highly competitive and evolving industry; (e) our ability to respond and adapt to changes in technology and customer behavior; (f) our ability to protect our intellectual property and to develop, maintain and enhance a strong brand; and (g) other factors (including the risks contained in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024). Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260116123656/en/

New Era Energy & Digital, Inc. Investor and Media Contact:

Investor Relations

[email protected]

Tel +1 475 477 9401

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Utilities Oil/Gas Energy Artificial Intelligence Data Management Engineering Technology Manufacturing

MEDIA: