[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12625-12626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06382]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-3691]
Determination That CHLOR-TRIMETON ALLERGY 12 HOUR
(Chlorpheniramine Maleate) Extended Release Tablets, 8 Milligrams and
12 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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 CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine
maleate) extended release tablets, 8 milligrams (mg) and 12 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not withdrawn from sale for reasons of safety or effectiveness.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: Katelyn Mineo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-1054.
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.
CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended
release tablets, 8 mg and 12 mg, are the subject of NDA 007638, held by
Bayer HealthCare LLC (Bayer) and initially approved on August 15, 1950.
CHLOR-TRIMETON ALLERGY 12 HOUR is indicated for temporary relief of the
following symptoms due to hay fever or other upper respiratory
allergies: sneezing; runny nose; itchy, watery eyes; itching of the
nose or throat.
In the 2005 NDA 007638 Annual Report received on October 14, 2005,
Bayer notified FDA that CHLOR-TRIMETON ALLERGY 12 HOUR
(chlorpheniramine maleate) extended release tablets, 8 mg, were being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book. In a letter dated February
8, 2018, Bayer notified FDA that CHLOR-TRIMETON ALLERGY 12 HOUR
(chlorpheniramine maleate) extended
[[Page 12626]]
release tablets, 12 mg, were being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book.
Avanthi, LLC, c/o KVK-TECH, INC., submitted a citizen petition
dated September 27, 2018 (Docket No. FDA-2018-P-3691), under 21 CFR
10.30, requesting that the Agency determine whether CHLOR-TRIMETON
ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8
mg, were withdrawn from sale for reasons of safety or effectiveness.
Although the citizen petition did not address the 12 mg 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 CHLOR-TRIMETON ALLERGY 12 HOUR
(chlorpheniramine maleate) extended release tablets, 8 mg and 12 mg,
were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate), extended
release tablets, 8 mg and 12 mg, were withdrawn for reasons of safety
or effectiveness.
We have carefully reviewed our files for records concerning the
withdrawal of CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine
maleate), extended release tablets, 8 mg and 12 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 CHLOR-TRIMETON
ALLERGY 12 HOUR (chlorpheniramine maleate), extended release tablets, 8
mg and 12 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: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06382 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P