Levitra FAQ

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.

• Levitra does not cure erectile dysfunction; it manages symptoms.
• Combining Levitra with certain antibiotics or antifungals may alter its effectiveness.
• Always follow the healthcare provider’s instructions for dosage and timing.
• Levitra is usually taken without regard to meals, but high-fat meals may delay action.
• Patients should report any allergic reactions such as rash or swelling.
• Use with caution in patients already taking blood pressure medications.
• Men with history of stroke or heart attack should consult a doctor before use.
• Levitra’s labeling includes warnings about potential side effects and interactions.

ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs.

Conditions treated by Levitra and Viagra

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Does Levitra have fewer side effects than Viagra?

Enter a search term or FR citation e.g. 88 FR 38230 FR 78782024-13208USDA09/05/24RULE0503-AA39SORN Choosing an item from full text search results will bring you to those results. Pressing enter in the search box will also bring you to search results. Choosing an item from suggestions will bring you directly to the content. 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That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness This table of contents is a navigational tool, processed from the headings within the legal text of Federal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. 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 levitra professional for sale to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. 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.

Is Levitra or Cialis more effective?

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. 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.

Viagra™ Side Effects

Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 2,287 as of 05/28/2026 at 8:15 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. 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. Respira Therapeutics, Inc.

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.

• Levitra was one of the first medications introduced for erectile dysfunction.
• Its mechanism involves relaxation of smooth muscle in penile tissue.
• Men should avoid taking Levitra with heavy meals to ensure rapid action.
• The medication’s safety profile is well-documented in scientific literature.
• Levitra may be prescribed alongside other therapies for ED management.
• Regular medical check-ups are recommended during treatment.
• Patients should be aware of potential drug interactions with Levitra.
• Avoid combining Levitra with recreational drugs, especially stimulants.

On our own initiative, we have also determined whether those strengths were withdrawn for safety or effectiveness reasons.

Warnings of Levitra and Viagra

As with Viagra, Levitra pills must be taken at least one hour prior to attempts at sexual intercourse to be effective. No direct comparison of the effectiveness of Levitra versus Viagra has been published to date. According to the American Foundation for Urologic Disease, Inc., erectile dysfunction is defined as the consistent inability to achieve and maintain an erection sufficiently to permit satisfactory sexual intercourse. It is estimated that there are 15 to 30 million men with ED in the United States, and 152-million cases of ED worldwide. Levitra is marketed by Bayer AG and GlaxoSmithKline.

Serious side effects

The study was funded by a grant from Bayer. This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov. The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. 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.

The petitioner has identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness.

• Levitra is marketed by Bayer Pharmaceuticals in many countries worldwide.
• It may be prescribed for off-label uses, such as pulmonary hypertension.
• Levitra's effects can last up to 4-5 hours, providing a window for sexual activity.
• Patients should avoid heavy meals before taking Levitra, as they can delay absorption.
• Precautions include avoiding abrupt alcohol or drug use before taking the medication.
• Levitra is sometimes used as an alternative to Viagra and Cialis.
• Side effects are usually mild but should be reported to a doctor if persistent.
• Levitra can interact with other medications, so full medical history is important.

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.

• Levitra has been shown to enhance erectile function in clinical studies.
• It is not classified as a controlled substance but still requires caution.
• Side effects usually diminish after the body adjusts to the medication.
• Patients should inform their doctor of all health issues before starting Levitra.
• In some cases, Levitra may be used temporarily or as needed.
• Regular blood pressure monitoring is recommended when using Levitra.
• Levitra should be stored safely away from children and pets.
• Discuss all medication options with a healthcare provider to find the best treatment.

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.

Coverage and cost comparison of Levitra vs. Viagra

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. Daniel Ritterbeck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.

Coverage and cost comparison of Levitra vs. Cialis

He also provided oversight and comment on the article. Only ten percent of men with ED are currently being treated for the condition, said Dr. Mulhall. Levitra, like Viagra, will increase awareness that erectile dysfunction is a medical condition and that there are powerful treatments now available. The Weill Cornell Sexual Medicine Program is committed to education, treatment, and research of disorders of sexual health affecting men and women.

How is vardenafil supplied (dosage forms)?

The Program aims to improve quality of life for the patient and their partner. Following treatment, ninety-five percent of our male patients are able to maintain erections and achieve successful penetration, said Dr. Mulhall. Two-thirds of patients respond to first-line oral therapies, such as Viagra. For those who do not respond, we offer penis injections and suppositories, as well as penile implants. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products.