[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]
-----------------------------------------------------------------------
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Withdrawn From Sale for Reasons of Safety or Effectiveness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.
-----------------------------------------------------------------------
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milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for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