Notice2022-12920
Determination That THEO-DUR (Theophylline) Extended-Release Tablets, 100 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
June 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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or we) has determined that THEO-DUR (theophylline) extended-release tablets, 100 milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 87 Issue 116 (Thursday, June 16, 2022)</title>
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[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36329-36330]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Tablets, 100 Milligrams and 300 Milligrams, Were Not Withdrawn From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milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of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,
<a href="/cdn-cgi/l/email-protection#76381f051e1758251e171e36101217581e1e0558111900"><span class="__cf_email__" data-cfemail="e5ab8c968d84cbb68d848da5838184cb8d8d96cb828a93">[email protected]</span></a>.
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
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