Patients taking alpha-blockers should not initiate vardenafil therapy with the orally disintegrating tablet.
Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes
| Storage Parameter | Recommended Condition | Notes |
|---|---|---|
| Temperature | Below 25°C (77°F) | Store in a cool, dry place |
| Humidity | Avoid excessive moisture | Keep away from water |
| Light exposure | Keep in original container, protect from light | Prevent degradation |
| Shelf life | 2-3 years from manufacturing date | Check expiration date |
before sexual activity Comments: Sexual stimulation is required for a response to treatment.
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mg tablets approved under New Drug Application (NDA) 021400 and held by Bayer Healthcare Pharmaceuticals Inc. has been withdrawn for reasons of safety or effectiveness; CLOSED Document page views are updated periodically throughout the day and are cumulative counts for this document. 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. 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has determined that Levitra (vardenafil hydrochloride) oral tablets, 5 milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness.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. 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. CrCl: 30 to 80 mL/min: No adjustment recommended.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra Gold | 100 mg | 60 + 4 Pills | 201.34€ 191.75€ | |
| Apcalis SX Oral Jelly | 20mg | 17 + 4 Sachets | 95.52€ 90.97€ | |
| Kamagra | 100mg | 60 + 4 Pills | 201.34€ 191.75€ | |
| Viagra Generic | 25mg | 10 Pills | 25.19€ 23.99€ | |
| Levitra Generic | 60mg | 90 + 6 Pills | 291.82€ 277.92€ | |
| Levitra Generic | 20mg | 60 + 6 Pills | 131.11€ 124.87€ | |
| Cialis Generic | 10mg | 10 Pills | 31.41€ 29.91€ | |
| Viagra Generic | 25mg | 60 + 4 Pills | 71.99€ 68.56€ | |
| Kamagra Polo | 100 mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Kamagra Gold | 50 mg | 360 + 6 Pills | 713.95€ 679.95€ | |
| Cialis Generic | 20mg | 360 + 10 Pills | 427.34€ 406.99€ | |
| Viagra Generic | 200mg | 20 Pills | 61.69€ 58.75€ | |
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
| Cialis Super Active | 20mg | 180 + 20 Pills | 521.59€ 496.75€ | |
| Levitra Professional | 20mg | 30 Pills | 119.12€ 113.45€ | |
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ | |
| Viagra Generic | 200mg | 10 Pills | 40.96€ 39.01€ |
Comment: The orally disintegrating tablet (brand Staxyn) can be
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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 tadalis 20 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. used in patients with mild, moderate or severe renal impairment.
Mild hepatic dysfunction (Child-Pugh A): No adjustment recommended.
Moderate hepatic dysfunction (Child-Pugh B): 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity. The maximum dose should not exceed 10 mg.
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 erection tablets new drug application (NDA). 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 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. 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. Severe hepatic dysfunction (Child-Pugh C): Use should be avoided.
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. 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. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons sex medicine 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. Applies to the following strengths: 2.5 mg; 5 mg; 10 mg; 20 mg Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability. Maximum dose: 20 mg once a day Initial dose: 5 mg orally once a day Sexual stimulation is required for a response to treatment. A time interval between dosing should be considered when administering this drug concomitantly with alpha-blockers.