Determination That Theophylline Oral Solution, 80 Milligrams/15 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 9789 [2011-3784]
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Federal Register / Vol. 76, No. 35 / Tuesday, February 22, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–P–0257]
Determination That Theophylline Oral
Solution, 80 Milligrams/15 Milliliters,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that theophylline oral solution, 80
milligrams (mg)/15 milliliters (mL), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for theophylline
oral solution, 80 mg/15 mL, if all other
legal and regulatory requirements are
met.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Nancy Hayes, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–3601.
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 approved
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 only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
VerDate Mar<15>2010
16:51 Feb 18, 2011
Jkt 223001
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).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
Theophylline oral solution, 80 mg/15
mL, is the subject of ANDA 087449,
held by Roxane Laboratories, Inc.
(Roxane), and initially approved on
September 15, 1983. ANDA 087449 was
identified in the Orange Book as the
listed drug for theophylline oral
solution, 80 mg/15 mL.
According to the latest version of the
approved labeling for theophylline oral
solution, 80 mg/15 mL, theophylline is
indicated for the treatment of the
symptoms and reversible airflow
obstruction associated with chronic
asthma and other chronic lung diseases,
such as emphysema and chronic
bronchitis. Roxane notified FDA by
letter dated August 4, 2008, that it was
no longer marketing theophylline oral
solution, 80 mg/15 mL and requested
that ANDA 087449 be withdrawn.
Theophylline oral solution, 80 mg/15
mL was moved to the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Silarx Pharmaceuticals, Inc. (Silarx or
petitioner), submitted a citizen petition
to FDA dated May 29, 2009 (Docket No.
FDA–2009–P–0257), under 21 CFR
10.30, requesting that the Agency accept
an ANDA submitted by Silarx for
theophylline oral solution 80 mg/15 mL,
referencing ANDA 087449 as the listed
drug. FDA cannot approve the
petitioner’s ANDA or any ANDA unless
it first determines whether ANDA
087449 was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records, FDA has
determined, under § 314.161, that
theophylline oral solution, 80 mg/15
mL, ANDA 087449, was not withdrawn
from sale for reasons of safety or
effectiveness. The petitioner identified
no data or other information suggesting
that theophylline oral solution, 80 mg/
15 mL, was withdrawn from sale for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
theophylline oral solution, 80 mg/15
mL, from sale. We have also
independently evaluated relevant
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
9789
literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list theophylline oral
solution, 80 mg/15 mL, 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. ANDAs that refer
to theophylline oral solution, 80 mg/15
mL, may be approved by the Agency if
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: February 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3784 Filed 2–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Urban Indian Health
Programs; Announcement Type:
Limited Competition, Continuation;
Funding Announcement Number:
HHS–2011–IHS–UIHP–0001
Catalogue of Federal Domestic Assistance
Number: 93.193
Key Dates: Application Deadline Date:
March 23, 2011.
Review Period: April 25–27, 2011.
Earliest Anticipated Start Date: May
16, 2011.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS),
Office of Urban Indian Health Programs
(OUIHP), announces the FY 2011
limited competition, continuation grants
for continued operation support for the
4-in-1 Title V grants to make health care
services more accessible for American
Indians and Alaska Natives (AI/AN)
residing in urban areas. This program is
authorized under the authority of the
Snyder Act, 25 U.S.C. 1652, 1653, 1660a
of Title V of the Indian Health Care
Improvement Act (IHCIA), Public Law
94–437, as amended.
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Notices]
[Page 9789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3784]
[[Page 9789]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-P-0257]
Determination That Theophylline Oral Solution, 80 Milligrams/15
Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
theophylline oral solution, 80 milligrams (mg)/15 milliliters (mL), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for theophylline oral solution, 80 mg/15 mL, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nancy Hayes, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.
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 approved 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 only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
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 generally known 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). Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
Theophylline oral solution, 80 mg/15 mL, is the subject of ANDA
087449, held by Roxane Laboratories, Inc. (Roxane), and initially
approved on September 15, 1983. ANDA 087449 was identified in the
Orange Book as the listed drug for theophylline oral solution, 80 mg/15
mL.
According to the latest version of the approved labeling for
theophylline oral solution, 80 mg/15 mL, theophylline is indicated for
the treatment of the symptoms and reversible airflow obstruction
associated with chronic asthma and other chronic lung diseases, such as
emphysema and chronic bronchitis. Roxane notified FDA by letter dated
August 4, 2008, that it was no longer marketing theophylline oral
solution, 80 mg/15 mL and requested that ANDA 087449 be withdrawn.
Theophylline oral solution, 80 mg/15 mL was moved to the ``Discontinued
Drug Product List'' section of the Orange Book.
Silarx Pharmaceuticals, Inc. (Silarx or petitioner), submitted a
citizen petition to FDA dated May 29, 2009 (Docket No. FDA-2009-P-
0257), under 21 CFR 10.30, requesting that the Agency accept an ANDA
submitted by Silarx for theophylline oral solution 80 mg/15 mL,
referencing ANDA 087449 as the listed drug. FDA cannot approve the
petitioner's ANDA or any ANDA unless it first determines whether ANDA
087449 was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency
records, FDA has determined, under Sec. 314.161, that theophylline
oral solution, 80 mg/15 mL, ANDA 087449, was not withdrawn from sale
for reasons of safety or effectiveness. The petitioner identified no
data or other information suggesting that theophylline oral solution,
80 mg/15 mL, was withdrawn from sale for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of theophylline oral solution, 80 mg/15 mL,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events and have found no
information that would indicate that this product was withdrawn from
sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list theophylline oral
solution, 80 mg/15 mL, 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. ANDAs that refer to theophylline oral solution, 80 mg/15
mL, may be approved by the Agency if 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: February 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3784 Filed 2-18-11; 8:45 am]
BILLING CODE 4160-01-P
