[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Page 59803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1879]


Determination That PREXXARTAN (Valsartan) Oral Solution, 20 
Milligrams/5 Milliliters and 80 Milligrams/20 Milliliters, Was 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 PREXXARTAN (valsartan) oral solution, 20 milligrams 
(mg)/5 milliliters (mL) and 80 mg/20 mL, was not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDAs) for valsartan 
oral solution, 20 mg/5 mL and 80 mg/20 mL, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510, [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 
(Sec.  314.162 (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.
    PREXXARTAN (valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL, 
is the subject of NDA 209139, held by Carmel Biosciences, Inc., and 
initially approved on December 19, 2017. PREXXARTAN is indicated for 
hypertension in adults and children 6 years and older, to lower blood 
pressure; for heart failure by significantly reducing hospitalization 
for patients who are unable to swallow valsartan tablets; and for 
stable left ventricular failure or left ventricular dysfunction 
following myocardial infarction.
    PREXXARTAN (valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL, 
is currently listed in the ``Discontinued Drug Product List'' section 
of the Orange Book. Additionally, Carmel Biosciences has never marketed 
PREXXARTAN (valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL. In 
previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, 
May 21, 1996), the Agency has determined that, for purposes of 
Sec. Sec.  314.161 and 314.162, never marketing an approved drug 
product is equivalent to withdrawing the drug from sale.
    Novitium Pharma LLC submitted a citizen petition dated January 30, 
2020 (Docket No. FDA-2020-P-0511), under 21 CFR 10.30, requesting that 
the Agency determine whether PREXXARTAN (valsartan) oral solution, 20 
mg/5 mL, was withdrawn from sale for reasons of safety or 
effectiveness. Although the citizen petition did not address the 80 mg/
20 mL strength, that strength has also been discontinued. On our own 
initiative, we have also determined whether that strength was 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 PREXXARTAN (valsartan) oral solution, 20 mg/5 
mL and 80 mg/20 mL, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that this drug product was withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of PREXXARTAN (valsartan) oral 
solution, 20 mg/5 mL and 80 mg/20 mL, 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 not withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list PREXXARTAN 
(valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL, 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. ANDAs that refer to PREXXARTAN 
(valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL, may 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: September 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20965 Filed 9-22-20; 8:45 am]
BILLING CODE 4164-01-P