[Federal Register Volume 84, Number 23 (Monday, February 4, 2019)]
[Notices]
[Pages 1469-1470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00847]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-P-1877 and FDA-2018-P-3730]
Determination That ESBRIET (Pirfenidone) Film Coated Tablets, 534
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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 ESBRIET (pirfenidone), film coated tablets, 534
milligrams (mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for pirfenidone, film coated tablets, 534
mg, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-6650.
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drug was withdrawn from sale for reasons of safety or effectiveness (21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.
ESBRIET (pirfenidone), film coated tablets, 534 mg, is the subject
of NDA 208780, held by Genentech, Inc., and initially approved on
January 11, 2017. ESBRIET is indicated for the treatment of idiopathic
pulmonary fibrosis. ESBRIET (pirfenidone), film coated tablets, 534 mg,
is currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book. Laurus Labs Ltd. submitted a citizen petition dated
May 14, 2018 (Docket No. FDA-2018-P-1877), and Aziant Drug Research
Solutions Pvt. Ltd. Submitted a citizen petition dated October 1, 2018
(FDA-2018-P-3730), under 21 CFR 10.30, requesting that the Agency
determine whether ESBRIET (pirfenidone), film coated tablets, 534 mg,
was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that ESBRIET (pirfenidone), film coated
tablets, 534 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioners have 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 ESBRIET (pirfenidone), film coated
tablets, 534 mg, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have found no information that would indicate that this drug product
was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ESBRIET
(pirfenidone), film coated tablets, 534 mg, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug
[[Page 1470]]
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to this drug product,
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: January 17, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00847 Filed 2-1-19; 8:45 am]
BILLING CODE 4164-01-P