[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27901-27902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-2060]


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Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for 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.

FOR FURTHER INFORMATION CONTACT: Daniel Ritterbeck, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-4673, [email protected].

SUPPLEMENTARY INFORMATION: 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).
    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 (Sec.  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

[[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. 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 Sec.  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 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.

    Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09365 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P