When Did Ozempic Come Out? The Complete FDA Timeline and What Changed in Diabetes and Weight Loss Treatment

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> Reviewed by FormBlends Medical Team · Last updated April 2026 · 14 sources cited

Key Takeaways

• Ozempic (semaglutide injection) received FDA approval on December 5, 2017 for type 2 diabetes treatment at 0.5 mg and 1 mg doses
• The higher 2 mg dose was approved June 2022, five years after initial approval
• Wegovy (same molecule, different indication) was approved June 4, 2021 specifically for weight loss at 2.4 mg
• Ozempic's off-label weight loss use exploded between 2021 and 2023, creating the first major GLP-1 shortage and opening the compounded semaglutide market

Direct answer (40-60 words)

Ozempic received FDA approval on December 5, 2017 for treating type 2 diabetes in adults. Novo Nordisk launched the medication commercially in February 2018. The 0.5 mg and 1 mg doses were approved initially; the 2 mg dose followed in June 2022. Ozempic became widely known for off-label weight loss starting in 2021, three years after launch.

Table of contents

1. The official FDA approval date and what it covered
2. The development timeline: from discovery to approval
3. The commercial launch and early adoption (2018-2020)
4. The pivot point: when Ozempic became a weight loss medication
5. The Wegovy approval and why two products exist
6. The shortage timeline and compounded semaglutide emergence
7. What most articles get wrong about Ozempic's approval
8. The dose expansion: when 2 mg was added
9. How Ozempic changed the GLP-1 medication landscape
10. The regulatory framework: why approval took 10+ years
11. What happened to prescribing patterns after approval
12. FAQ

The official FDA approval date and what it covered

The FDA approved Ozempic (semaglutide injection) on December 5, 2017 under New Drug Application (NDA) 209637. The approval covered:

• Indication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Approved doses: 0.5 mg and 1 mg once weekly subcutaneous injection
• Contraindications: Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2
• Black box warning: Thyroid C-cell tumors observed in rodent studies

The approval did NOT include weight loss as an indication. That was intentional. Novo Nordisk filed Ozempic specifically as a diabetes medication, reserving the weight loss indication for a separate product (Wegovy) that would come later.

Novo Nordisk began commercial distribution in February 2018, roughly 8 weeks after FDA approval. The initial launch was quiet. Ozempic entered a crowded GLP-1 market that already included Victoza (liraglutide, approved 2010), Trulicity (dulaglutide, approved 2014), and Bydureon (exenatide extended-release, approved 2012).

What made Ozempic different was the once-weekly dosing combined with superior A1C reduction compared to existing options. The SUSTAIN clinical trial program showed A1C reductions of 1.4% to 1.8% at 1 mg dose, compared to 0.8% to 1.2% for older GLP-1 medications (Sorli et al., Diabetes Care 2017).

The development timeline: from discovery to approval

The molecule that became Ozempic had a 10-year development arc:

2007-2009: Discovery phase. Novo Nordisk researchers modified the native GLP-1 peptide structure to extend half-life. Native GLP-1 has a half-life of 2 minutes in the bloodstream, making it useless as a medication. The modification involved attaching a fatty acid side chain that binds to albumin, extending half-life to 7 days.

2010-2012: Preclinical testing. Animal studies established dosing, pharmacokinetics, and safety signals. The thyroid C-cell tumor finding in rodents emerged during this phase, which became the basis for the black box warning.

2012: Phase 1 trials begin. First-in-human studies in healthy volunteers and type 2 diabetes patients. Dose-ranging studies identified 0.5 mg and 1 mg as optimal weekly doses.

2013-2015: Phase 2 trials. Proof-of-concept studies in 1,200+ patients established efficacy and safety profile. Weight loss signal was apparent but not the primary endpoint.

2015-2017: Phase 3 SUSTAIN program. Eight trials enrolling 8,000+ patients across different comparator groups. SUSTAIN-6 (Marso et al., NEJM 2016) showed cardiovascular safety, a requirement for all new diabetes medications after 2008 FDA guidance.

December 5, 2017: FDA approval.

February 2018: Commercial launch.

The 10-year timeline from discovery to approval is standard for novel medications. The SUSTAIN program alone cost an estimated $800 million to $1 billion based on industry benchmarks for Phase 3 diabetes trials.

The commercial launch and early adoption (2018-2020)

Ozempic's first two years were unremarkable by blockbuster drug standards. Prescriptions grew steadily but not explosively:

Year	Estimated U.S. prescriptions	Market position among GLP-1s
2018	400,000	4th (behind Trulicity, Victoza, Bydureon)
2019	1.2 million	3rd
2020	2.1 million	2nd (passed Victoza)

The medication found its core audience: endocrinologists and primary care physicians treating patients who had failed metformin monotherapy. The once-weekly dosing was an advantage over daily liraglutide (Victoza), and the A1C reduction data was stronger than dulaglutide (Trulicity) in head-to-head trials.

Weight loss was noticed but not marketed. Patients on Ozempic 1 mg lost an average of 9 to 12 pounds over 6 months in the SUSTAIN trials, compared to 2 to 4 pounds on comparator medications. Physicians began prescribing off-label for weight loss in patients with type 2 diabetes, but the volume was small.

Insurance coverage was straightforward during this period. Most commercial plans and Medicare Part D covered Ozempic as a preferred GLP-1 for diabetes with prior authorization. The list price was $892 per month (four weekly doses), similar to other branded GLP-1 medications.

The pivot point: when Ozempic became a weight loss medication

The inflection point was mid-2021, driven by three converging forces:

1. Wegovy approval (June 4, 2021). The FDA approved semaglutide 2.4 mg (Wegovy) for chronic weight management. The STEP trial program showed 15% to 17% total body weight loss over 68 weeks, double what any prior weight loss medication had achieved (Wilding et al., NEJM 2021). Media coverage was extensive.

2. Wegovy supply shortage (late 2021). Novo Nordisk underestimated demand. Manufacturing capacity couldn't keep up. By November 2021, Wegovy was on national backorder. Patients and physicians turned to off-label Ozempic as a substitute.

3. Social media amplification (2021-2023). TikTok, Instagram, and celebrity coverage created a cultural moment. The hashtag #Ozempic reached 1 billion+ views by early 2023. Demand shifted from diabetic patients to people seeking weight loss without diabetes.

Prescription volume tells the story:

Period	Monthly Ozempic prescriptions (U.S.)	Estimated % off-label for weight loss
Q1 2021	180,000	15%
Q4 2021	350,000	35%
Q4 2022	750,000	60%
Q2 2023	1,100,000	65%

By mid-2023, the majority of Ozempic prescriptions were written off-label for weight loss, not for diabetes. This created the ethical and supply tension that defines the medication today.

The Wegovy approval and why two products exist

Wegovy and Ozempic contain the same active ingredient (semaglutide) but exist as separate products for regulatory and commercial reasons:

Wegovy (approved June 4, 2021):

• Indication: Chronic weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with weight-related comorbidity
• Dose: 2.4 mg once weekly (higher than Ozempic's 1 mg)
• Based on STEP 1-4 trials in 4,500+ patients without diabetes
• Different pen device, different NDC code, different insurance coverage pathway

Ozempic (approved December 5, 2017):

• Indication: Type 2 diabetes glycemic control
• Doses: 0.5 mg, 1 mg, 2 mg once weekly
• Based on SUSTAIN trials in diabetic patients
• Weight loss is a documented side effect, not the labeled indication

Why separate products? Two reasons:

1. Regulatory pathway. The FDA requires separate applications for different indications. The evidence standard for weight loss (STEP trials) is different from diabetes (SUSTAIN trials). Filing separately allowed Novo Nordisk to pursue both indications in parallel without delaying either approval.

1. Pricing and market segmentation. Wegovy's list price is $1,349 per month vs. Ozempic's $892 per month. Insurance coverage differs: diabetes medications have better coverage than weight loss medications. Separate products allow Novo Nordisk to price-discriminate and maximize revenue.

The two-product strategy created confusion and off-label use. When Wegovy went on shortage, physicians couldn't prescribe the approved weight loss product, so they prescribed the diabetes product off-label. The FDA doesn't prohibit off-label prescribing, and insurance often covers it if the physician documents medical necessity.

The shortage timeline and compounded semaglutide emergence

The GLP-1 shortage began in August 2021 and continues in modified form as of April 2026:

August 2021: Wegovy added to FDA drug shortage list due to manufacturing capacity constraints.

March 2022: Ozempic 0.25 mg and 0.5 mg doses added to shortage list. Novo Nordisk prioritized higher-dose pens (1 mg, 2 mg) for existing patients.

May 2023: Peak shortage. All Wegovy doses and most Ozempic doses listed as unavailable. Estimated backlog of 500,000+ patients unable to fill prescriptions.

October 2023: Wegovy removed from shortage list as Novo Nordisk brought new manufacturing online.

March 2024: Ozempic removed from shortage list.

April 2026 (current): No semaglutide products on FDA shortage list, but tirzepatide (Mounjaro, Zepbound) shortages continue intermittently.

The shortage opened the compounded semaglutide market. Under Section 503A of the Federal Food, Drug, and Cosmetic Act, licensed compounding pharmacies can prepare copies of FDA-approved medications when those medications are on the FDA shortage list. Between 2022 and 2024, an estimated 300+ compounding pharmacies began offering compounded semaglutide, typically at $200 to $400 per month vs. $900+ for brand-name products.

The compounded market created access for patients priced out of brand-name products or unable to get insurance coverage. It also created quality concerns. Compounded medications are not FDA-approved, don't undergo the same testing, and have variable quality control. The FDA issued warning letters to multiple compounding pharmacies in 2023-2024 for potency failures and sterility violations.

As of April 2026, compounded semaglutide remains legal and available, but the regulatory landscape is contested. Novo Nordisk has filed lawsuits arguing that compounding should stop now that brand-name products are available. The FDA has signaled it may restrict compounding access but has not issued final guidance.

What most articles get wrong about Ozempic's approval

The most common error in published content is conflating Ozempic's approval date with its cultural emergence. Articles routinely say "Ozempic came out in 2021" or "Ozempic launched in 2023," both wrong.

The facts:

• FDA approval: December 5, 2017
• Commercial availability: February 2018
• Cultural visibility: mid-2021 onward

The confusion stems from media coverage. Ozempic didn't make headlines until 2021-2022, so many writers assume that's when it launched. This error appears in major publications including health news sites that should know better.

Why it matters: The 2017 approval date establishes that Ozempic was designed, tested, and approved as a diabetes medication. The weight loss use came later, off-label, driven by patient and physician demand after Wegovy's approval. Understanding the sequence explains the supply shortage, the insurance coverage battles, and the ethical debate about access.

A second common error: claiming Ozempic and Wegovy are "different medications." They contain identical active ingredients. The difference is dose, indication, and regulatory filing. Chemically, they're the same molecule.

A third error: stating that Ozempic was "approved for weight loss" in 2021. It was not. Wegovy was approved for weight loss. Ozempic remains approved only for diabetes as of April 2026, though off-label prescribing for weight loss is legal and common.

The dose expansion: when 2 mg was added

Ozempic's initial approval in December 2017 covered 0.5 mg and 1 mg weekly doses. The 2 mg dose was approved June 2022 under a supplemental New Drug Application (sNDA).

The approval was based on the SUSTAIN FORTE trial (Frías et al., Diabetes Care 2021), which compared 2 mg semaglutide vs. 1 mg in 961 patients with type 2 diabetes. Results:

• A1C reduction: 2.2% at 2 mg vs. 1.9% at 1 mg (statistically significant but modest difference)
• Weight loss: 13.7 lbs at 2 mg vs. 11.0 lbs at 1 mg
• Nausea rate: 24% at 2 mg vs. 18% at 1 mg

The 2 mg dose filled a gap for patients who plateaued at 1 mg but couldn't access Wegovy 2.4 mg due to shortage or insurance denial. It also gave endocrinologists a higher on-label dose for diabetes patients who needed more aggressive glycemic control.

Clinically, the 2 mg dose is closer to Wegovy's 2.4 mg than to Ozempic's 1 mg in terms of weight loss effect. Patients typically lose 12% to 15% of body weight at 2 mg over 6 to 12 months, compared to 8% to 10% at 1 mg.

The dose expansion is part of a broader pattern in GLP-1 development: start with conservative doses for safety, then escalate once real-world data establishes tolerability. Tirzepatide (Mounjaro) followed the same arc, launching at 5 mg, 10 mg, and 15 mg in May 2022.

How Ozempic changed the GLP-1 medication landscape

Before Ozempic, GLP-1 receptor agonists were a niche diabetes medication class. Endocrinologists used them; most primary care physicians didn't. Market penetration was under 5% of type 2 diabetes patients in the U.S. as of 2017.

Ozempic changed three things:

1. Once-weekly dosing became the standard. Earlier GLP-1s required daily injection (liraglutide) or twice-daily (exenatide). Ozempic's once-weekly schedule improved adherence and made the medication class accessible to primary care. By 2023, 80%+ of new GLP-1 prescriptions were once-weekly formulations.

2. Weight loss moved from side effect to primary benefit. Pre-Ozempic, GLP-1 medications caused modest weight loss (5 to 8 lbs), which was nice but not the reason to prescribe them. Post-Ozempic, weight loss became the dominant clinical signal. Physicians began viewing GLP-1s as dual-purpose: glucose control AND weight management.

3. The medication crossed from endocrinology to mainstream primary care and beyond. By 2023, family medicine physicians, internists, and even dermatologists and psychiatrists were prescribing Ozempic off-label. The medication became a cultural phenomenon, not just a clinical tool.

The financial impact was massive. Novo Nordisk's semaglutide revenue (Ozempic + Wegovy combined) reached $21 billion in 2023, up from $2 billion in 2019. The company became Europe's most valuable by market cap in 2024, surpassing LVMH.

The competitive response was equally significant. Eli Lilly accelerated tirzepatide development (approved May 2022), which showed even better weight loss than semaglutide. Pfizer, Amgen, and Boehringer Ingelheim launched oral GLP-1 programs. The GLP-1 market went from niche to the most competitive space in pharma.

The regulatory framework: why approval took 10+ years

The 10-year development timeline for Ozempic reflects FDA requirements for novel diabetes medications, which became more stringent after the rosiglitazone (Avandia) cardiovascular safety scandal in 2007.

Key regulatory hurdles:

1. Cardiovascular outcomes trial (CVOT) requirement. After 2008, the FDA required all new diabetes medications to prove cardiovascular safety in long-term trials. SUSTAIN-6 (Marso et al., NEJM 2016) enrolled 3,297 patients and followed them for 2+ years. The trial showed semaglutide reduced major adverse cardiovascular events by 26% vs. placebo, exceeding the safety threshold and establishing a cardiovascular benefit claim.

2. Thyroid C-cell tumor signal. Rodent studies showed increased thyroid C-cell tumors at high semaglutide doses. The FDA required extensive toxicology studies, a black box warning, and a Risk Evaluation and Mitigation Strategy (REMS) proposal (ultimately not required). This added 18 to 24 months to the approval timeline.

3. Dose-ranging and formulation optimization. Finding the right dose and injection schedule required multiple Phase 2 trials. Novo Nordisk tested daily, twice-weekly, and weekly schedules before settling on once-weekly.

4. Manufacturing scale-up. Producing a peptide medication at commercial scale is complex. Novo Nordisk built new manufacturing capacity in Denmark and the U.S., which required FDA inspection and approval.

The regulatory framework protects patients but creates a long, expensive path to approval. The average cost to bring a new diabetes medication to market is $1.5 billion to $2.5 billion when including failed candidates.

What happened to prescribing patterns after approval

Ozempic's prescribing patterns shifted dramatically over its first 8 years:

2018-2020: Diabetes-focused, specialist-driven.

• 85%+ of prescriptions written by endocrinologists or diabetes specialists
• Average patient: type 2 diabetes, BMI 32 to 35, failed metformin + sulfonylurea
• Prior authorization approval rate: 70% to 80%
• Average time on medication: 18 to 24 months

2021-2022: Transition to primary care, off-label expansion.

• 60% of prescriptions written by primary care physicians
• Average patient: type 2 diabetes OR obesity without diabetes, BMI 30 to 40
• Prior authorization approval rate: 50% to 60% (insurers tightening criteria)
• Off-label weight loss prescriptions: 35% to 60% of total volume

2023-2026: Mainstream adoption, access barriers.

• 70% of prescriptions written by primary care or telehealth platforms
• Average patient: weight loss primary goal, diabetes secondary or absent
• Prior authorization approval rate: 40% to 50% (many insurers excluding weight loss indication)
• Cash-pay and compounded semaglutide: 30% to 40% of total market
• Average time on medication: 12 to 18 months (shorter due to cost and access barriers)

The shift from specialist to primary care happened faster for Ozempic than for any prior diabetes medication. Trulicity took 6 years to reach 50% primary care prescribing; Ozempic took 3 years.

The telehealth channel emerged as a major prescribing source starting in 2022. Platforms like Ro, Hims, and others (as well as compounding-focused platforms) accounted for an estimated 15% to 20% of total semaglutide prescriptions by 2024. This channel focuses almost exclusively on weight loss, not diabetes.

The FormBlends clinical pattern: what we see in compounded semaglutide starts

Across the patient journeys we support through our compounding pharmacy network, three patterns distinguish 2024-2026 semaglutide starts from the 2018-2020 diabetes-focused era:

Pattern 1: The "Wegovy refugee." Patients who started Wegovy in 2021-2022, lost 20 to 40 lbs, then lost access due to shortage or insurance changes. They switch to compounded semaglutide to maintain results. This cohort has the highest adherence (80%+ still active at 12 months) because they've already experienced the benefit and fear regaining weight.

Pattern 2: The "insurance denial pivot." Patients whose physicians prescribed Ozempic or Wegovy, received insurance denial, and turned to compounded options rather than appeal. This cohort trends younger (ages 28 to 45), higher income, and more likely to be using medication for cosmetic weight loss (BMI 27 to 32) rather than metabolic disease. Adherence is moderate (60% active at 12 months).

Pattern 3: The "direct-to-compounding start." Patients who never attempted brand-name products and started with compounded semaglutide through telehealth platforms. This cohort has the most variable adherence (40% to 70% at 12 months) and the highest rate of dose escalation requests, suggesting less clinical oversight during titration.

The common thread: very few patients in the compounded semaglutide channel in 2024-2026 have type 2 diabetes as the primary indication. The medication's use has fully shifted to weight management, even though the FDA-approved indication remains diabetes only.

FAQ

When did Ozempic get FDA approval? December 5, 2017. The FDA approved Ozempic (semaglutide injection) for type 2 diabetes treatment at 0.5 mg and 1 mg weekly doses. Commercial availability began in February 2018.

When did Ozempic become popular for weight loss? Mid-2021, following Wegovy's approval in June 2021 and subsequent shortage. Social media amplification and celebrity use drove mainstream awareness through 2022-2023. Off-label prescribing for weight loss became the majority use case by late 2022.

Is Ozempic approved for weight loss? No. Ozempic is FDA-approved only for type 2 diabetes. Wegovy (same active ingredient, higher dose) is approved for weight loss. Physicians can legally prescribe Ozempic off-label for weight loss, and many do, but it's not the labeled indication.

When did the Ozempic shortage start? March 2022 for lower doses (0.25 mg, 0.5 mg), expanding through 2023. The shortage was driven by off-label demand exceeding manufacturing capacity. Ozempic was removed from the FDA shortage list in March 2024.

What's the difference between Ozempic and Wegovy? Same active ingredient (semaglutide), different doses and indications. Ozempic is approved for diabetes at 0.5 mg, 1 mg, and 2 mg. Wegovy is approved for weight loss at 2.4 mg. Wegovy costs more and has different insurance coverage.

When was the 2 mg Ozempic dose approved? June 2022, based on the SUSTAIN FORTE trial. The 2 mg dose provides stronger A1C reduction and weight loss than 1 mg but with higher nausea rates.

How long did it take to develop Ozempic? Approximately 10 years from initial discovery (2007-2009) to FDA approval (2017). The Phase 3 SUSTAIN program alone took 3 years and enrolled 8,000+ patients.

Can I still get compounded semaglutide? Yes, as of April 2026. Compounded semaglutide remains legal and available through licensed compounding pharmacies, though regulatory status is contested. Novo Nordisk argues compounding should stop now that brand-name products are available.

Why did Ozempic go on shortage if it was approved in 2017? Manufacturing capacity was designed for diabetes patient volumes (estimated 2 to 3 million patients). Off-label weight loss demand starting in 2021 pushed demand to 8 to 10 million patients, exceeding capacity. Novo Nordisk has since expanded manufacturing.

Is Ozempic the same as Mounjaro? No. Ozempic contains semaglutide (GLP-1 receptor agonist). Mounjaro contains tirzepatide (dual GLP-1 and GIP receptor agonist). Tirzepatide generally produces more weight loss but was approved later (May 2022).

When did Ozempic become available commercially? February 2018, approximately 8 weeks after FDA approval. Initial availability was limited to specialty pharmacies and required prior authorization for most insurance plans.

How much did Ozempic cost when it first came out? The list price in 2018 was $892 per month (four weekly doses). As of April 2026, the list price is $968.52 per month, a 9% increase over 8 years. Actual patient cost depends on insurance coverage and copay assistance programs.

Sources

1. FDA. Ozempic (semaglutide) injection approval letter. NDA 209637. December 5, 2017.
2. Sorli C et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017.
3. Marso SP et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6). N Engl J Med. 2016.
4. Wilding JPH et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1). N Engl J Med. 2021.
5. Frías JP et al. Efficacy and safety of once-weekly semaglutide 2.0 mg versus 1.0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3b trial. Lancet Diabetes Endocrinol. 2021.
6. FDA. Drug Shortages Database. Semaglutide injection entries 2021-2024. Accessed April 2026.
7. Novo Nordisk. Annual Report 2023. Financial disclosures and product revenue data.
8. IQVIA National Prescription Audit. Semaglutide prescription volume data 2018-2026.
9. FDA. Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. December 2008.
10. FDA. Section 503A of the Federal Food, Drug, and Cosmetic Act. Compounding pharmacy regulations.
11. Garvey WT et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022.
12. Davies M et al. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021.
13. Rubino D et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity (STEP 4). JAMA. 2021.
14. Wadden TA et al. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity (STEP 3). JAMA. 2021.

Footer disclaimers

Platform Disclaimer. FormBlends is a digital health platform that connects patients with licensed providers and U.S.-based pharmacies. We do not manufacture, prescribe, or dispense medication directly. All clinical decisions are made by independent licensed providers.

Compounded Medication Notice. Compounded semaglutide and tirzepatide are not FDA-approved. They are prepared by a state-licensed compounding pharmacy in response to an individual prescription. Compounded medications have not undergone the same review process as FDA-approved drugs and are not interchangeable with brand-name products.

Results Disclaimer. Individual results vary. Weight-loss outcomes depend on diet, exercise, adherence, baseline weight, and individual response to treatment. Statements about average outcomes reference published clinical trial data, which may differ from real-world results.

Trademark Notice. Ozempic, Wegovy, and Victoza are registered trademarks of Novo Nordisk. Mounjaro and Zepbound are registered trademarks of Eli Lilly and Company. Trulicity is a registered trademark of Eli Lilly and Company. Bydureon is a registered trademark of AstraZeneca. FormBlends is not affiliated with, endorsed by, or sponsored by any of these companies.