[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Notices]
[Page 9789]
From the Federal Register Online via the Government Publishing 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Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or 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.

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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not withdrawn from sale for reasons of safety or effectiveness.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