A total of 601 men with mild to severe erectile dysfunction (ED) were enrolled in this multi-centre, randomized, double-blind, placebo-controlled trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil.
- Vardenafil may interact with medications for blood pressure.
- The drug is metabolized in the liver, caution in liver disease.
- Avoid excessive alcohol to reduce side effects.
- Do not take Vardenafil with other PDE5 inhibitors.
- It is important to stay calm and relaxed during use.
- Sexual health consultations can optimize treatment outcomes.
- Be aware of potential side effects and seek help if needed.
- Always check expiration date before use.
- It’s not a substitute for a healthy lifestyle.
- Use only as prescribed by your healthcare professional.
- Contact a doctor if Vardenafil does not work as expected.
Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the International Index of Erectile Function (IIEF). In the intent-to-treat population (n=580), the changes from baseline for 5, 10 and 20 mg vardenafil (1.2, 1.3 and 1.5, respectively) were all improved (P<0.001) over placebo (0.2) for Q3 and were similarly improved for Q4 (1.4, 1.5 and 1.7) compared to placebo (0.5) (P<0.001).
- Vardenafil should not be taken with fatty foods for quick absorption.
- It is effective for men with erectile dysfunction of various causes.
- The medication is available in tablet form for oral intake.
- The onset of action is typically within 30-60 minutes.
- Use of Vardenafil can improve confidence and intimacy quality.
- It is not meant for daily use but as needed before sex.
- Some may experience prolonged erections; seek help if prolonged.
- Precautions include avoiding grapefruit juice which can affect levels.
- Patients with kidney or liver issues should inform their doctor.
- Sexual activity has inherent cardiovascular risks, which Vardenafil may potentiate.
- Discontinuation should be discussed with a healthcare provider.
All vardenafil doses improved all IIEF domains compared to placebo (P<0.001). The percentage of successful intercourses was between 71 and 75% for the three vardenafil doses.
- Vardenafil is contraindicated for women and children.
- It can be used by men with diabetes-related erectile issues.
- It's effective for men with prostate-related erectile problems.
- Always measure dosage carefully to avoid adverse effects.
- The medication is absorbed in the gastrointestinal tract.
- Vardenafil does not protect against sexually transmitted infections.
- Use caution if combining with other medications affecting circulation.
- Some people may experience indigestion or stomach pain.
- It is important to report any severe side effects immediately.
- The drug's efficacy may be affected by certain medical conditions.
- Always complete the full course prescribed by your doctor.
For the 20 mg dose, 80% of the patients experienced improved erections (GAQ) compared to 30% for placebo. Most frequent treatment-emergent adverse super p force uk events were headache (7–15%), flushing (10–11%) and up to 7% for dyspepsia or rhinitis. Vardenafil treatment resulted in a high efficacy and low adverse-event profile in a population with mixed ED etiologies.
- Vardenafil dosage adjustments may be needed for older adults.
- It may pose risks in men with low blood pressure.
- Always adhere to the prescribed therapeutic regimen.
- It is not recommended to exceed 20 mg per dose.
- Vardenafil is not intended for use with other ED medications.
- Precise timing of doses ensures efficacy and safety.
- The drug may improve sexual confidence and satisfaction.
- Side effects are usually temporary and dose-related.
- Alcohol and high-fat foods can delay onset of action.
- Avoid using Vardenafil if allergies to it are known.
- Proper hydration can enhance its effectiveness.
This is a preview of subscription content, access via your institution Receive 12 print issues and online access Instant access to the full article PDF. Effect of erectile dysfunction on frequency of intercourse: a population based prevalence study in Finland. The prevalence of erectile dysfunction in four countries: Italy, Brazil, Malaysia and Japan. Poster presented at 1st International Consultation on Erectile Dysfunction, Paris, 1–3 July 1999 The prevalence of erectile dysfunction in four countries: Italy, Brazil, Malaysia and Japan. Poster presented at 1st International Consultation on Erectile Dysfunction, Paris, 1–3 July 1999 Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study.
7. Future Perspectives and Research Direction
submitted a citizen petition dated August 29, 2022 (Docket No. FDA-2022-P-2060), under 21 CFR 10.30, requesting that the Agency determine whether Levitra (vardenafil hydrochloride) oral tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not address the 5 mg and 10 mg strengths, those strengths have also been discontinued. On our own initiative, we have also determined whether those strengths were withdrawn for safety or effectiveness reasons. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn for reasons of safety or effectiveness.
Food and Diet:
The petitioner has identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, in the “Discontinued Drug Product List” section of the Orange Book. Erectile dysfunction in general medicine practice: prevalence and clinical correlates. Int J Impot Res 2000 12, 41–45 Erectile dysfunction in general medicine practice: prevalence and clinical correlates. Int J Impot Res 2000 12, 41–45 Incidence of erectile dysfunction in men 40 to 69 y old: longitudinal results from the Massachusetts Male Aging Study.
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Incidence of erectile dysfunction in men 40 to 69 y old: longitudinal results from the Massachusetts Male Aging Study.
| Study | Percentage of Patients Reporting Improvement | Sample Size | Notes |
|---|---|---|---|
| Clinical Trial A | 75% | 150 | Overall effectiveness high |
| Clinical Trial B | 80% | 200 | Similar results across studies |
| Real-world data | 70-85% | Varies | Effectiveness observed in practice |
Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa. Int J Impot Res 1998 10, 239–246 Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa.
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Determination That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect. FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document. Requests that the FDA determine whether LEVITRA® (vardenafil HCl) 20 mg tablets approved under New Drug Application (NDA) 021400 and held by Bayer Healthcare Pharmaceuticals Inc.
How is vardenafil supplied (dosage forms)?
has been withdrawn for reasons of safety or effectiveness; CLOSED Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 2,287 as of 05/28/2026 at 10:15 am EDT This document is also available in the following formats: 2023-09365 as it appeared on Public Inspection on 05/02/2023 at 8:45 am. It was viewed 13 times while on Public Inspection. If you are using public inspection listings for legal research, you should verify the contents of the documents against a final, official edition of the Federal Register.
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Only official editions of the Federal Register provide legal notice of publication to the public and judicial notice to the courts under 44 U.S.C. Published Document: 2023-09365 (88 FR 27901) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format. The Food and Drug Administration (FDA or Agency) has determined that Levitra (vardenafil hydrochloride) oral tablets, 5 milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements. Cross-cultural development of a quality of life measure for men with erection difficulties.
Dosing & Uses
Daniel Ritterbeck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Corresponding author
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA ed tablets that does not refer to a listed drug.
What is vardenafil, and what is it used for?
Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, are ( printed page 27902) the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and initially approved on August 19, 2003. Levitra is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction. In letters dated September 26, 2019, September 24, 2020, and September 20, 2021, Bayer HealthCare Pharmaceuticals, Inc. notified FDA that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, respectively, were being discontinued, and FDA moved the drug products to the “Discontinued Drug Product List” section of the Orange Book. Respira Therapeutics, Inc. Effect of erectile dysfunction on health-related quality of life.
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The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products. Additional ANDAs for these drug products may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Vardenafil, a novel selective phosphodiesterase type 5 inhibitor, was evaluated in its first large-scale at-home trial.
