Federal Register / Vol. 76, No. 35 / Tuesday, February 22, 2011 / Notices 9789 

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Was Not Withdrawn From Sale for 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not withdrawn from sale for reasons of 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was withdrawn from sale for reasons of 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 § 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 

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. 

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