FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced   U.S. Food and Drug Administration (FDA)  approval of Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive PKU.

"We are excited to have reached this important milestone for those affected by PKU," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "The broad labeling reflects the potential of Sephience to meet the significant unmet need of PKU patients. The Sephience clinical data along with our expertise in launching rare disease therapies position Sephience to become the future standard of care. Our experienced customer facing teams are ready to bring this therapy to children and adults with PKU in the United States as quickly as possible."

The FDA approval is based on the evidence of significant efficacy and safety from the

Phase 3 APHENITY trial as well as durability of treatment effect in the APHENITY long-term extension study.

"The approval marks an exciting milestone for the PKU community," said Catherine Warren, Executive Director of the National PKU Alliance. "This progress brings renewed hope, and we are eager to see the positive impact this new treatment option will have on advancing care and potentially improving quality of life for individuals of all ages and PKU subtypes that respond to this therapy."

Sephience was recently granted marketing authorization by the European Commission. Review of approval applications is ongoing in several other countries including Japan and Brazil.

About Sephience (sepiapterin)

Sephience is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients with phenylketonuria (PKU). Sephience is a natural precursor of the enzymatic co-factor BH4, a critical co-factor for phenylalanine hydroxylase (PAH). Through its mechanism of action, Sephience is able to effectively reduce blood phenylalanine (Phe) levels and has the potential to treat a broad range of PKU patients. Sephience is approved in the European Economic Area and the United States.

Indication and Important Safety Information

Indication

Sephience is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). Sephience is to be used in conjunction with a phenylalanine (Phe)-restricted diet.

Contraindications

None

Important Safety Information

Treatment with Sephience should be directed by physicians knowledgeable in the management of PKU. Biochemical response to Sephience can only be determined by a therapeutic trial with careful monitoring of ongoing dietary and nutritional balance to ensure adequate Phe control.

Warnings and Precautions

Increased Bleeding: Sephience may increase the risk of bleeding. Bleeding events, including superficial hematomas, prolonged bleeding, and heavy menstrual bleeding have occurred in patients treated with Sephience. Inform patients about the risk of bleeding associated with Sephience and have patients follow up with their healthcare provider should such a bleeding event occur. Consider treatment interruption with Sephience in patients with active bleeding.

Hypophenylalaninemia: Some pediatric patients receiving Sephience experienced hypophenylalaninemia. Monitor blood Phe levels during treatment and modify the dosage of Sephience and/or dietary protein and Phe intake as needed to ensure adequate blood Phe level control. Frequent blood monitoring is recommended in the pediatric population.

Interaction with Levodopa: In a 10-year post-marketing safety surveillance program for a non-PKU indication using another drug that is a phenylalanine hydroxylase (PAH) activator, 3 patients with underlying neurological disorders experienced seizures, exacerbation of seizures, over-stimulation, and irritability during co-administration with levodopa. Monitor patients who are receiving levodopa for changes in neurological status during treatment with Sephience.

Adverse Reactions

Most common adverse reactions with Sephience (≥2% and > placebo) were diarrhea, headache, abdominal pain, hypophenylalaninemia, feces discoloration, and oropharyngeal pain.

Drug Interactions

Avoid concomitant use of drugs known to inhibit folate synthesis dihydrofolate reductase (DHFR) (e.g., trimethoprim, methotrexate, trimetrexate, pemetrexed, pralatrexate, raltitrexed, and piritrexim) while taking Sephience. Concomitant administration of such drugs may reduce sepiapterin metabolism to BH4. If concomitant use is not avoidable, monitor blood Phe levels.

Sephience and PDE-5 inhibitors (e.g., sildenafil, vardenafil, or tadalafil) induce vasorelaxation and may reduce blood pressure. Monitor for signs and symptoms of hypotension.

For medical information, product complaints, or to report an adverse event, please call 1–866–562–4620 or email at usmedinfo@ptcbio.com.

https://en.wikipedia.org/wiki/Sepiapterin

FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria

FDA Approves Enbumyst (bumetanide) Nasal Spray for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease

Corstasis Therapeutics Inc., announced the U.S. Food and Drug Administration (FDA)  approval of  Enbumyst (bumetanide nasal spray). Enbumyst is indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults.

Addressing a Critical Unmet Need

Edema and fluid overload remain the leading causes of hospitalization and readmission for patients with CHF, cirrhosis, and chronic kidney disease. An estimated 6.7 million Americans live with heart failure, and fluid overload drives over 1 million hospitalizations annually, accounting for billions of dollars in U.S. health care expenditures. Oral loop diuretics can be limited by poor gastrointestinal absorption and delayed onset, while intravenous (IV) therapy requires a hospital or infusion setting, often associated with higher resource utilization and increased healthcare expenditure.

Enbumyst demonstrated rapid absorption and predictable diuretic response in clinical studies, with a similar effect on diuresis, natriuresis and urinary potassium excretion when compared to IV bumetanide injection. Enbumyst adds a new self-administered outpatient diuretic therapy, which may help bridge the gap between oral and IV diuretics for treating edema in patients with CHF, liver disease and kidney disease. The FDA-approved Prescribing Information for Enbumyst does not include a boxed warning. Please refer to the Important Safety Information below.

“The FDA approval of Enbumyst represents a meaningful advancement in the treatment of edema for patients and providers,” said Ben Esque, Chief Executive Officer of Corstasis Therapeutics.

“Enbumyst was designed in direct collaboration with cardiologists to address practical challenges in the outpatient care setting,” said Dr. Brian Kolski Chief Medical Director of Corstasis and Director, Non-Invasive Vascular Lab at the Orange County Heart Institute and Director of Structural Heart Disease at Providence St Joseph Hospital in Orange, California.

Commercial Strategy and Market Opportunity

Corstasis expects to launch Enbumyst in the U.S. in the fourth quarter of 2025, targeting cardiologists, nephrologists, hepatologists, outpatient heart failure clinics and integrated delivery networks (IDNs). The company is also preparing a robust market access strategy, including real-world outcomes data and payer partnerships, to support rapid adoption and coverage.

The U.S. market for outpatient diuretic therapies addressing edema associated with CHF, and hepatic and renal disease is estimated to represent a multi-billion-dollar opportunity annually, driven by the high prevalence of heart failure and chronic kidney disease, as well as the unmet need for therapies that reduce costly hospitalizations and readmissions.

“Enbumyst offers the potential to change the standard of care by enabling earlier, outpatient intervention,” said Dr. Anuradha Lala-Trindade, Director of Heart Failure Research at the Mount Sinai Fuster Heart Hospital in New York. “This innovation may meaningfully improve outcomes while potentially easing the economic burden on the healthcare system.”

About Enbumyst

Enbumyst is a nasal spray loop diuretic indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

Enbumyst is indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

IMPORTANT SAFETY INFORMATION

Enbumyst is contraindicated in patients with anuria, who are in hepatic coma and have a history of hypersensitivity to bumetanide.

Enbumyst is a diuretic that may cause fluid, electrolyte, and metabolic abnormalities. Excessive fluid loss can lead to dehydration, decreased blood volume, and increased risk of blood clots. Abnormalities may include changes in blood electrolytes, nitrogen, glucose, and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses or who do not get enough electrolytes by mouth.

If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide.

Although unlikely at the recommended doses, the potential for ototoxicity must be considered a risk of intravenous therapy, at high doses, repeated frequently in the face of renal excretory function impairment.

Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause.

Advise lactating women treated with Enbumyst to monitor their infants for excessive urine output, dehydration, and lethargy.

Ref: https://en.wikipedia.org/wiki/Bumetanide

FDA Approves Enbumyst (bumetanide) Nasal Spray for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

In continuation of my update on Nitisinone

Cycle Pharmaceuticals announced the FDA approval of  Harliku (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU.1

Launching in July 2025, Harliku will be the first and only FDA-approved treatment for AKU,1 an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys, and heart.2 Patients with AKU often develop pain, reduced joint mobility, and require large joint replacements; the symptoms impede their physical functionality, emotional well-being, and quality of life.2,3

The approval of Harliku is based on data from a randomized, no-treatment controlled study of 40 patients with AKU. As part of the intramural research program of the National Human Genome Research Institute at the National Institutes of Health (NIH), Dr. Wendy J. Introne, MD and her team showed that nitisinone helped patients improve pain, energy levels, and physical functioning after three years of treatment, assessed using the 36-Item Short-Form Survey.4

Steve Fuller, Chief Strategy Officer of Cycle Pharmaceuticals commented,

“We are deeply grateful for Cycle’s collaboration with Dr. Wendy Introne, Dr. Bill Gahl, and the broader team at the NIH, whose pioneering work laid the foundation for this FDA approval. We look forward to making Harliku available to U.S. AKU patients as soon as possible and remain committed to supporting the AKU community to the fullest extent of our capabilities.”

“The approval of Harliku is an important advance for the AKU community. Our scientific team has translated decades of research into launching nitisinone as a new treatment option, and we stand hopeful that it can ease the significant burden of AKU,” said Dr. Wendy J. Introne, MD, of NIH’s National Human Genome Research Institute (NHGRI).

Building on the company’s previous success in rare diseases, Harliku will be Cycle Pharmaceuticals’ eighth commercial product in the US.

Indications

Harliku™ is indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU).

Important Safety Information

Do not prescribe Harliku to patients allergic to nitisinone or any other contained ingredients.

Warnings and Precautions:

Ocular Symptoms and Hyperkeratotic Plaques Due to Elevated Plasma Tyrosine Level:

Ocular signs and symptoms including keratitis, corneal opacities, corneal irritation, corneal ulcers, conjunctivitis, eye pain, and photophobia, have been reported in patients.

Perform slit-lamp examination prior to treatment and regularly thereafter. Reexamine patients if symptoms develop or tyrosine levels are > 500 micromole/L. Assess plasma tyrosine levels in patients with an abrupt change in neurological status.

Perform a clinical laboratory assessment, including plasma tyrosine levels, in patients with an abrupt change in neurological status.

Leukopenia and Severe Thrombocytopenia

In clinical trials, patients with hereditary tyrosinemia type 1 (HT-1) treated with another oral formulation of nitisinone and dietary restriction, developed reversible leukopenia, thrombocytopenia, or both. No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia. Monitor platelet and white blood cell counts during Harliku therapy.

Adverse Reactions:

The most common adverse reactions (≥1%) reported in patients with AKU taking nitisinone in clinical trials are elevated tyrosine levels, thrombocytopenia and keratitis.

Drug Interactions:

Nitisinone is a moderate CYP2C9 inhibitor and a weak CYP2E1 inducer. Potential clinical impact of Harliku administration with CYP2C9 substrates. Reduce the dosage of the co-administered drugs metabolized by CYP2C9 by half. Additional dosage adjustments may be needed.

Nitisinone is an inhibitor of OAT1/OAT3. Potential clinical impact of administration with OAT1/OAT3 substrates. Patients should be monitored for potential adverse reactions.

Use in Specific Populations:

Pregnancy: Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

Lactation: The developmental and health benefits of breastfeeding should be considered against the mother’s clinical need for Harliku, along with potential adverse effects on the breastfed infant from Harliku or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of Harliku have not been established in pediatric patients with AKU.

Geriatric Use: Insufficient data from clinical studies of Harliku to determine if patients ≥ 65 years of age respond differently. Elderly patients should be cautious reflecting any decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

https://en.wikipedia.org/wiki/Nitisinone

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection

In continuation of my update lenacapavir

Gilead Sciences, Inc. (Nasdaq: GILD)  announced  the U.S. Food and Drug Administration (FDA)  approval of Yeztugo (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.

“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”

The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP. CDC data show that all populations in the U.S. are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps for women, Black/African American and Hispanic/Latino people, and people in the U.S. South. Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options—by both healthcare providers and consumers—contribute to this low uptake of PrEP across multiple populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that, in 2023, more than 100 people were diagnosed with HIV every day in the U.S.

“Yeztugo could be the transformative PrEP option we’ve been waiting for—offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta. “A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.”

FDA approval of Yeztugo is supported by high efficacy and demonstrated safety data in two clinical trials

The FDA approval of Gilead’s New Drug Applications (NDAs) for Yeztugo was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

Yeztugo received FDA approval under Priority Review. Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy.

Gilead’s U.S. access strategy for Yeztugo is designed to enable broad uptake and availability for individuals with and without insurance coverage

In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo. Additionally, for eligible commercially insured individuals with commercial insurance, Gilead’s Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.

Gilead is also committed to helping to ensure that people without insurance in the U.S. will be able to benefit from Yeztugo. For those who are eligible, Gilead’s Advancing Access medication assistance program will provide Yeztugo free of charge.

https://en.wikipedia.org/wiki/Lenacapavir

FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection

FDA Approves Xifyrm (meloxicam) Injection for the Management of Moderate-to-Severe Pain in Adults

In continuation of update on Meloxicam

Azurity Pharmaceuticals, Inc.  announced the U.S. Food and Drug Administration (FDA)  approval of  Xifyrm (meloxicam injection) an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing.

Xifyrm is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Xifyrm provides a non-opioid analgesic in a 30mg/mL vial for IV bolus injection over 15 seconds. Because of delayed onset of analgesia, Xifyrm alone is not recommended for use when rapid onset of analgesia is required.

“Xifyrm demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management,” said Ron Scarboro, CEO at Azurity Pharmaceuticals. “Xifyrm addresses an important clinical need, especially for patients requiring a non-opioid component to multimodal analgesia strategies.”

Xifyrm will be available in the coming weeks. For full prescribing information, including boxed warning and safety profile, please visit www.Xifyrm.com

https://en.wikipedia.org/wiki/Meloxicam

FDA Approves Xifyrm (meloxicam) Injection for the Management of Moderate-to-Severe Pain in Adults

FDA Approves Widaplik (telmisartan, amlodipine and indapamide) for the Treatment of Hypertension

George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, announced  the US Food and Drug Administration (FDA)  approval of  Widaplik™ (telmisartan, amlodipine and indapamide), formerly known as “GMRx2”, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure.

Widaplik is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Widaplik, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability.

Indapamide

Amlodipine

Globally recognized treatment guidelines now recommend the use of single pill combination therapy for most patients and acknowledge the benefit of early use of combination therapy.

In the US, nearly half of adults have hypertension and only around one in four have their blood pressure under control. Hypertension is a major risk factor for coronary heart disease, stroke and heart failure and is estimated to cause 460,000 deaths in the US each year.

Mark Mallon, Chief Executive Officer of George Medicines, said: “Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control. Widaplik can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure. With its triple combination efficacy, established safety profile, good tolerability and its availability in a single pill, Widaplik has the potential to address key challenges in current hypertension treatment approaches. With planning underway for the upcoming US commercial launch of Widaplik, and further regulatory submissions in other territories anticipated during 2025, George Medicines is well-positioned to positively impact the global burden of hypertension.”

Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and Past President of the World Hypertension League, said: “I am very excited and pleased to have Widaplik approved for the treatment of hypertension in the US. Single pill combination antihypertensive therapy has great potential to improve hypertension control in the US and worldwide. Most patients with hypertension need multiple therapies to achieve their blood pressure goals. The new dose options available with Widaplik offer a treatment regimen that could benefit a broad range of patients, including those just starting treatment.”

The FDA approval is based on positive results from two international Phase 3 trials, which compared Widaplik against placebo and against dual combinations of its component drugs.

In both trials Widaplik significantly improved blood pressure and control rates vs comparators. In clinical trials, the most common adverse event reported in patients treated with Widaplik is symptomatic hypotension. Widaplik is contraindicated in patients with anuria, known hypersensitivity to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product. In patients with diabetes, Widaplik is not to be co-administered with aliskiren. A boxed warning in the labeling informs physicians and patients to discontinue Widaplik as soon as possible after pregnancy is detected due to fetal toxicity.

The US commercial launch of Widaplik is anticipated in Q4 2025.

George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company’s Widaplik development program built on earlier research by The George Institute, including the 700-patient TRIUMPH trial undertaken in Sri Lanka in 2016/17, which found that among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill led to an increased proportion of patients achieving their target blood pressure goal versus usual care.

George Medicines is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm.

About Widaplik™ (GMRx2)

Widaplik is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, available in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg. Widaplik is indicated for the treatment of hypertension, including as initial treatment, to lower blood pressure.

Its development is backed by a comprehensive clinical program, including two pivotal Phase 3 studies, published in 2024 in the Journal of the American College of Cardiology and The Lancet.

In these trials the triple combination demonstrated significantly reduced blood pressure (BP) and improved BP control rates, when compared against dual therapy and against placebo. In both trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events.

GMRx2 was investigated in the Nigerian VERONICA trial, which compared the triple combination with standard of care and reported better BP lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol.

A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing.

INDICATIONS

Widaplik is a prescription medicine used to treat high blood pressure (hypertension) in adults. Widaplik may be used as the first medicine to lower your high blood pressure if your healthcare provider decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack.

https://en.wikipedia.org/wiki/Indapamide

https://en.wikipedia.org/wiki/Amlodipine

FDA Approves Widaplik (telmisartan, amlodipine and indapamide) for the Treatment of Hypertension