[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36329-36330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12920]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-1154]


Determination That THEO-DUR (Theophylline) Extended-Release 
Tablets, 100 Milligrams and 300 Milligrams, Were Not Withdrawn From 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, Agency, or we) has 
determined that THEO-DUR (theophylline) extended-release tablets, 100 
milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of 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: Nisha Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455, 
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved, and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act 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.
    THEO-DUR (theophylline) extended-release tablets, 100 mg and 300 
mg, are the subject of ANDA 085328, currently held by Merck & Co., Inc. 
(previously held by Schering Corporation),\1\ initially approved on 
April 12, 1979. THEO-DUR is indicated for the treatment of the symptoms 
and reversible airflow obstruction associated with chronic asthma and 
other chronic lung diseases, e.g., emphysema and chronic bronchitis.
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    \1\ In 2009, Schering Corporation merged with Merck and is now 
referred to as Merck & Co., Inc.
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    In a letter dated March 18, 2003, Schering Corporation requested 
withdrawal of ANDA 085328 for THEO-DUR (theophylline) extended-release 
tablets. In the Federal Register of May 5, 2004 (69 FR 25124), FDA 
announced that it was withdrawing approval of ANDA 085328, effective 
June 4, 2004.
    Lachman Consultants submitted a citizen petition dated October 25, 
2021 (Docket No. FDA-2021-P-1154), under 21 CFR 10.30, requesting that 
the Agency determine whether THEO-DUR (theophylline) extended-release 
tablets, 300 mg, were withdrawn from sale for reasons of safety or 
effectiveness.

[[Page 36330]]

Although the citizen petition did not address the 100-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 THEO-DUR (theophylline) extended-release 
tablets, 100 mg and 300 mg, were 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 THEO-DUR (theophylline) extended-
release tablets, 100 mg and 300 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 THEO-DUR 
(theophylline) extended-release tablets, 100 mg and 300 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: June 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12920 Filed 6-15-22; 8:45 am]
BILLING CODE 4164-01-P


