[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Notices]
[Pages 16519-16520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8264]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02P-0057]


Determination That Albuterol Sulfate Inhalation Solution 0.5% Was 
Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 16520]]

SUMMARY: The Food and Drug Administration (FDA) has determined that 
albuterol sulfate inhalation solution 0.5% (Ventolin) was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
albuterol sulfate inhalation solution 0.5%.

FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors 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 under a new drug 
application (NDA). Sponsors of ANDAs do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    Regulations also provide that the agency must make a determination 
as to 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 (21 CFR 314.161(a)(1)). FDA may not approve an ANDA 
that does not refer to a listed drug.
    Albuterol sulfate inhalation solution 0.5% is the subject of NDA 
19-269 held by GlaxoSmithKline. Albuterol sulfate inhalation solution 
0.5% is indicated for the relief of bronchospasm in patients with 
reversible obstructive airway disease and acute attacks of 
bronchospasm.
    On February 1, 2002, Nephron Pharmaceuticals Corp. submitted a 
citizen petition (Docket No. 02P-0057) under 21 CFR 10.30 to FDA 
requesting that the agency determine whether albuterol sulfate 
inhalation solution 0.5% was withdrawn from sale for reasons of safety 
or effectiveness. The agency has determined that albuterol sulfate 
inhalation solution 0.5% was not withdrawn for reasons of safety or 
effectiveness. In support of that finding, we note that GlaxoSmithKline 
notified the agency in July 2001 that albuterol sulfate inhalation 
solution 0.5% was being withdrawn from sale because of a decline in 
sales. FDA has independently evaluated relevant literature and data for 
adverse event reports and has found no information that would indicate 
that this product was withdrawn for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for reasons outlined previously, albuterol sulfate 
inhalation solution 0.5% was not withdrawn for reasons of safety or 
effectiveness. Accordingly, the agency will continue to list albuterol 
sulfate inhalation solution 0.5% 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 for reasons other than safety or effectiveness. ANDAs that 
refer to albuterol sulfate inhalation solution 0.5% may be approved by 
the agency.

    Dated: March 28, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8264 Filed 4-3-03; 8:45 am]
BILLING CODE 4160-01-S