[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12 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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not withdrawn from sale for reasons of safety or effectiveness.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