This section highlights FDA-related milestones and regulatory updates for drugs developed by Viatris (VTRS).
Over the past two years, Viatris has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Gwyn, VR-205, MR-107A-02, EFFEXOR, MR-141, Inpefa, and MR‑146. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Gwyn Lo FDA Regulatory Events
Gwyn Lo is a drug developed by Viatris for the following indication: norelgestromin and ethinyl estradiol transdermal system.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Gwyn Lo
- Announced Date:
- July 29, 2026
- Indication:
- norelgestromin and ethinyl estradiol transdermal system
Announcement
Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal system). Gwyn Lo is a new combined hormonal contraceptive (CHC) patch with low-dose estrogen.
AI Summary
Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal system), a new combined hormonal contraceptive patch containing low-dose estrogen. The approval was granted through the FDA’s 505(b)(2) pathway and was supported by results from the Phase 3 Luminous Study.
The study showed that Gwyn Lo was effective at preventing pregnancy and had a well-characterized safety profile. It also demonstrated strong patch adhesion. Additional Phase 1 studies found that the patch delivered medication consistently at different application sites and during activities or conditions such as sauna use, whirlpool exposure, treadmill exercise, and cold-water bathing.
Gwyn Lo is indicated to prevent pregnancy in women with a body mass index below 30 kg/m² who are appropriate candidates for combined hormonal contraception. Viatris expects the product to become commercially available later this year.
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VR-205 FDA Regulatory Events
VR-205 is a drug developed by Viatris for the following indication: Immunoglobulin A Nephropathy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VR-205
- Announced Date:
- June 29, 2026
- Indication:
- Immunoglobulin A Nephropathy
Announcement
Viatris Inc announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of developing end-stage renal disease.
AI Summary
Viatris Inc. said its Phase 3 study of VR-205, a targeted-release budesonide treatment also known as Nefecon, met its main goal in Japanese adults with primary immunoglobulin A nephropathy (IgAN). The trial tested 16 mg of VR-205 in patients at risk of kidney failure and followed them for nine months, with an added three-month follow-up period.
The medicine lowered the geometric mean urine protein-to-creatinine ratio by 33.75% from baseline at nine months, a result that was both statistically significant and clinically meaningful. Viatris said the safety and effectiveness seen in Japanese patients matched results from earlier global studies. The company noted that IgAN is a serious disease in Japan with no cure and a real risk of progressing to end-stage renal disease. Viatris is aiming to submit a New Drug Application in Japan by the end of 2026.
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MR-107A-02 FDA Regulatory Events
MR-107A-02 is a drug developed by Viatris for the following indication: Treatment of Moderate-to-Severe Acute Pain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MR-107A-02
- Announced Date:
- May 18, 2026
- Indication:
- Treatment of Moderate-to-Severe Acute Pain
Announcement
Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain. The FDA has assigned a PDUFA goal date of Dec. 27, 2026.
AI Summary
Viatris Inc. said the U.S. Food and Drug Administration has accepted for review its New Drug Application for MR-107A-02, a fast-acting form of meloxicam. The company is seeking approval of this non-opioid medicine to treat moderate-to-severe acute pain. The FDA has set a PDUFA goal date of Dec. 27, 2026, which is the target date for its decision.
Viatris said fast-acting meloxicam is part of its plan to grow value-added medicines through new formulations, delivery technologies, and added uses. The company aims to expand its portfolio with products that offer more options for patients and support long-term growth.
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EFFEXOR FDA Regulatory Timeline and Events
EFFEXOR is a drug developed by Viatris for the following indication: In adults with generalized anxiety disorder (GAD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EFFEXOR
- Announced Date:
- March 23, 2026
- Indication:
- In adults with generalized anxiety disorder (GAD).
Announcement
Viatris Inc announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Effexor® SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI), for the treatment of adults with generalized anxiety disorder (GAD).
AI Summary
Viatris Inc. announced that Japan’s Ministry of Health, Labour and Welfare has approved Effexor® SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), a serotonin‑noradrenaline reuptake inhibitor (SNRI), for the treatment of adults with generalized anxiety disorder (GAD). The company said this approval makes Effexor the first and only approved treatment option for GAD in Japan, addressing a significant unmet need for a condition that can severely reduce quality of life and disrupt daily activities. A recent survey found probable GAD in 7.6% of the Japanese general population.
The approval was supported by clinical data, including trials and a long‑term extension study in Japanese patients. Reported discontinuation rates due to treatment‑emergent adverse events (TEAEs) were 7.3% for Effexor versus 1.7% for placebo, with 3.9% versus 0.6% assessed as related to treatment. No serious TEAEs or TEAEs of severe intensity were observed in the Effexor group. Effexor is already approved for GAD in more than 80 countries outside Japan.
Read Announcement- Drug:
- EFFEXOR
- Announced Date:
- April 21, 2025
- Indication:
- In adults with generalized anxiety disorder (GAD).
Announcement
Viatris Inc. announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalized anxiety disorder (GAD), an indication for which no other treatment option is currently approved in Japan.
AI Summary
Viatris Inc. has filed applications with Japan’s Ministry of Health, Labor and Welfare (MHLW) seeking approval for Effexor SR Capsules (venlafaxine hydrochloride) to treat adults with generalized anxiety disorder (GAD). This filing targets a significant gap in Japan, where there is currently no approved treatment option for GAD. The application is backed by positive results from a Phase 3, placebo-controlled study conducted in Japan, where Effexor showed superior anxiolytic effects compared to placebo and met all secondary endpoints. Effexor, a serotonin-noradrenaline reuptake inhibitor (SNRI), is already approved in Japan for major depressive disorder and is used to treat GAD in more than 80 other countries. The efforts by Viatris aim to address the needs of patients who suffer from chronic, uncontrollable anxiety that affects their everyday activities and overall quality of life.
Read Announcement- Drug:
- EFFEXOR
- Announced Date:
- October 9, 2024
- Indication:
- In adults with generalized anxiety disorder (GAD).
Announcement
Viatris Inc. announced positive top-line results of its Phase 3 study (B2411367) in Japan evaluating the safety and efficacy of EFFEXOR® (venlafaxine) in adults with generalized anxiety disorder (GAD).
AI Summary
Viatris Inc. announced positive top-line results from its Phase 3 study (B2411367) in Japan, evaluating the safety and efficacy of EFFEXOR® (venlafaxine) for treating generalized anxiety disorder (GAD) in adults. The study met its primary objective by demonstrating superior anxiolytic effects compared to a placebo after 8 weeks, using the Hamilton Anxiety Rating Scale (HAM-A) as the key measurement. All seven secondary endpoints were also achieved, further supporting the efficacy of EFFEXOR® in reducing both psychic and somatic anxiety factors.
The treatment was generally well tolerated and its safety profile was consistent with previous studies in non-Japanese patients. With low rates of treatment discontinuation and a reduced incidence of new suicidal ideation compared to placebo, these results highlight the potential of EFFEXOR® as a promising treatment option for a significant unmet need in Japanese patients with GAD.
Read Announcement- Drug:
- EFFEXOR
- Announced Date:
- October 9, 2024
- Indication:
- In adults with generalized anxiety disorder (GAD).
Announcement
Viatris Inc. announced that Pharmaceuticals and Medical Devices Agency (PMDA) submission targeted for 2025
AI Summary
Viatris Inc. announced that it is aiming to submit its application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for EFFEXOR® in 2025. This submission is a key step in bringing a treatment option for generalized anxiety disorder (GAD) to a market with a significant unmet need, as there are currently no approved therapies for this condition in Japan. The decision follows positive top-line results from a Phase 3 study conducted in Japanese patients, where EFFEXOR® not only met its primary endpoint by showing significant superiority over placebo on the Hamilton Anxiety Rating Scale but also achieved all secondary efficacy endpoints. The study further confirmed that EFFEXOR® is generally well tolerated, with a safety profile consistent with its known use in non-Japanese patients.
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MR-141 FDA Regulatory Events
MR-141 is a drug developed by Viatris for the following indication: Treatment of Presbyopia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MR-141
- Announced Date:
- February 25, 2026
- Indication:
- Treatment of Presbyopia
Announcement
Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia.
AI Summary
Viatris Inc. said the U.S. Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) for MR-141, phentolamine ophthalmic solution 0.75%, seeking approval to treat presbyopia. The company expects a Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2026. Acceptance for review means the FDA will evaluate whether the application has enough data to consider a label expansion for treating age-related difficulty focusing on near objects.
Viatris develops MR-141 through a global licensing agreement with Opus Genetics, which gives Viatris exclusive rights to commercialize the product in the United States. If the FDA completes its review and approves the sNDA, MR-141 could become an additional treatment option for people with presbyopia. Viatris will follow the FDA’s review process and timelines leading up to the PDUFA date.
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Inpefa FDA Regulatory Events
Inpefa is a drug developed by Viatris for the following indication: Treatment of Heart Failure.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Inpefa
- Announced Date:
- January 20, 2026
- Indication:
- Treatment of Heart Failure
Announcement
Viatris Inc. announced the launch of Inpefa® (sotagliflozin) in the United Arab Emirates (UAE), the first country within the Viatris territories to commercialize the treatment.
AI Summary
Viatris Inc. announced the launch of Inpefa® (sotagliflozin) in the United Arab Emirates, the first country within Viatris’ territories to commercialize the treatment. The company said it plans additional launches in multiple countries over the next several years as part of a strategy to expand patient access in key markets.
Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment of heart failure. In the UAE it is authorized to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart-failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.
Viatris cited two large Phase 3 trials (SOLOIST‑WHF and SCORED) involving more than 11,800 patients that showed significant reductions in major heart-failure outcomes. Company leaders said the UAE launch builds on their cardiovascular experience and supports broader global submissions and future rollouts.
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MR‑146 FDA Regulatory Events
MR‑146 is a drug developed by Viatris for the following indication: Gene Therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MR‑146
- Announced Date:
- December 18, 2025
- Indication:
- Gene Therapy
Announcement
Viatris Inc. (announced four recent regulatory milestones spanning across all stages of its global pipeline:
AI Summary
Viatris Inc. said it reached four recent regulatory milestones that span all stages of its global pipeline, from early development through to commercialization. The company described these milestones as reflecting progress across different programs and geographies, involving regulatory filings, authorizations and favorable interactions with health authorities. Viatris said the advances strengthen its ability to move medicines toward patients and support its strategy of combining branded and generic capabilities to address broad healthcare needs worldwide.
Viatris also announced it will present at the 44th Annual J.P. Morgan Healthcare Conference on Jan. 13, 2026, with a live webcast available at investor.viatris.com. An archived recording will be posted after the event for a limited time.
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Meloxicam FDA Regulatory Events
Meloxicam is a drug developed by Viatris for the following indication: For the Treatment of Moderate-to-Severe Acute Pain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- meloxicam
- Announced Date:
- August 1, 2025
- Indication:
- For the Treatment of Moderate-to-Severe Acute Pain
Announcement
Viatris announced that five abstracts from its Phase 3 program evaluating novel fast-acting formulation of meloxicam (MR-107A-02) in moderate-to-severe acute surgical pain models will be presented at the PAINWeek 2025 national conference in Las Vegas from September 2-5, 2025.
AI Summary
In August 2025, Viatris announced that five abstracts from its Phase 3 program on MR-107A-02, a novel fast-acting meloxicam formulation, will be presented at PAINWeek 2025 in Las Vegas from September 2–5. These abstracts cover pharmacokinetic, efficacy, safety, and opioid-sparing data in moderate-to-severe acute surgical pain models.
Two pivotal studies in bunionectomy and herniorrhaphy demonstrated positive efficacy and safety outcomes, along with reduced opioid use compared to standard care. A pharmacokinetic poster will compare the absorption of a 15 mg MR-107A-02 tablet to a 15 mg dose of Mobic® in healthy adults. Live presentations will detail how MR-107A-02 manages pain and minimizes opioid reliance in postoperative settings.
All accepted Viatris abstracts are available on the PAINWeek website. These presentations aim to highlight MR-107A-02’s potential to improve pain management and support safer recovery after surgery.
Read Announcement- Drug:
- meloxicam
- Announced Date:
- May 8, 2025
- Indication:
- For the Treatment of Moderate-to-Severe Acute Pain
Announcement
Viatris Inc announced positive results from its Phase 3 program of the novel fast-acting formulation of meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain.
AI Summary
Viatris Inc. announced positive results from its Phase 3 study of a novel fast-acting meloxicam formulation (MR-107A-02) designed to treat moderate-to-severe acute pain. The study demonstrated that this innovative formulation delivers rapid pain relief, meeting key efficacy and safety endpoints. Researchers found that the product’s fast-acting properties may significantly improve patient outcomes by providing effective pain management in acute settings. Additionally, the favorable safety profile observed in the trial suggests that MR-107A-02 could become an important option for patients who need swift and reliable relief without compromising tolerability.
The promising Phase 3 results support Viatris’ commitment to addressing critical needs in pain management. The company looks forward to engaging with the FDA as it advances this breakthrough treatment toward potential approval, which could offer a valuable new therapy for those suffering from acute pain.
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MR-139 FDA Regulatory Events
MR-139 is a drug developed by Viatris for the following indication: For Blepharitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MR-139
- Announced Date:
- July 22, 2025
- Indication:
- For Blepharitis
Announcement
Viatris Inc. announced that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing.
AI Summary
Viatris Inc. announced that a randomized, double-masked, vehicle-controlled Phase 3 study of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis did not meet its primary endpoint of complete resolution of eyelid debris after six weeks of twice-daily dosing. Blepharitis is an inflammation of the eyelids characterized by redness, irritation and crusting at the eyelid margins. The trial enrolled 477 adults who applied the study ointment or matching placebo to their eyelids twice daily and were observed over a 12-week treatment period. Results showed no significant difference between the active treatment and vehicle in clearing debris at week six.
Viatris Chief R&D Officer Philippe Martin said that, given the study outcome, the company will evaluate appropriate next steps for the Phase 3 program. These may include revising the design of a planned additional Phase 3 trial to better address patients’ needs. Viatris thanked the patients and investigators who contributed to the trial and is assessing its development strategy for MR-139 in blepharitis.
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XULANE LO FDA Regulatory Events
XULANE LO is a drug developed by Viatris for the following indication: For Birth Control in Women of Childbearing Potential.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XULANE LO
- Announced Date:
- May 8, 2025
- Indication:
- For Birth Control in Women of Childbearing Potential
Announcement
Viatris Inc. announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential.
AI Summary
Viatris Inc. announced positive Phase 3 results for its investigational XULANE LO low dose weekly dermal patch. The study (NCT05139121) evaluated the contraceptive efficacy and safety of the patch, which releases 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day, in women of childbearing potential. With a Pearl Index of 4.14 and a cumulative pregnancy probability of 3.7% over 13 cycles, the patch showed effective contraceptive performance while maintaining a favorable safety profile. Most treatment-emergent side effects were reported as mild-to-moderate, and there were very few incidents of patch detachment or severe local reactions.
Viatris is encouraged by these results, noting the patch’s potential best-in-class adhesion and cycle control. The company plans to submit a New Drug Application to the U.S. FDA in the second half of 2025, reinforcing its commitment to providing women a reliable, reversible birth control method with a lower estrogen dose.
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Cenerimod FDA Regulatory Events
Cenerimod is a drug developed by Viatris for the following indication: In Lancet Rheumatology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cenerimod
- Announced Date:
- December 18, 2024
- Indication:
- In Lancet Rheumatology
Announcement
Viatris Inc. announced the publication of Phase 2b CARE study results evaluating the efficacy and safety of cenerimod in adults with moderate-to-severe systemic lupus erythematosus (SLE).
AI Summary
Viatris Inc. announced the publication of Phase 2b CARE study results showing that cenerimod, an investigational S1P1 receptor modulator, is effective and safe for adults with moderate-to-severe systemic lupus erythematosus (SLE). In the study, patients receiving a 4 mg dose of cenerimod experienced significant and sustained improvements in SLE symptoms compared to those on placebo, all while continuing their standard SLE therapies.
Additionally, biomarker data published in the Annals of the Rheumatic Diseases further clarified cenerimod’s mechanism of action. The analysis demonstrated that cenerimod works by lowering IFN-related proteins and gene expressions, confirming its multifaceted immunomodulatory effects. The trial also showed that cenerimod is generally well tolerated, supporting the decision to move forward with further Phase 3 studies.
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