[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Notices]
[Pages 39855-39856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-2290]


Determination That LEVITRA (Vardenafil Hydrochloride) Tablets, 
2.5 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or 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) tablets, 2.5 
milligrams (mg), were not withdrawn from sale for reasons of safety or 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 this drug product, and it will allow FDA to 
continue to approve ANDAs that refer to the product as long as they 
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Daniel J. 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: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
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) tablets, 2.5 mg, are the subject 
of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and 
initially approved on August 19, 2003. LEVITRA is a phosphodiesterase 5 
(PDE5) inhibitor indicated for the treatment of erectile dysfunction. 
LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, are currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book.
    In a letter dated March 22, 2018, Bayer HealthCare Pharmaceuticals, 
Inc., notified FDA that LEVITRA (vardenafil hydrochloride) tablets, 2.5 
mg, were being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Alembic Pharmaceuticals Limited submitted a citizen petition 
received on May 9, 2019 (Docket No. FDA-2019-P-2290), under 21 CFR 
10.30, requesting that the Agency determine whether LEVITRA (vardenafil 
hydrochloride) tablets, 2.5 mg, were withdrawn from sale for safety or 
effectiveness reasons and permit the filing of abbreviated new drug 
applications (ANDAs) referencing LEVITRA (vardenafil hydrochloride) 
tablets, 2.5 mg.
    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) tablets, 
2.5 mg, were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of LEVITRA (vardenafil 
hydrochloride) tablets, 2.5 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 this drug product was

[[Page 39856]]

not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list LEVITRA (vardenafil 
hydrochloride) tablets, 2.5 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 this drug product. Additional ANDAs for 
this drug product 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 this drug product should be 
revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17212 Filed 8-9-19; 8:45 am]
 BILLING CODE 4164-01-P