Document ID: FDA-2010-N-0318-0004
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications: Novartis Pharmaceuticals Corp. et al.; Correction
Posted Date: 2011-09-23T04:00Z

[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Page 59144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24400]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0318]

Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 
27 New Drug Applications and 58 Abbreviated New Drug Applications; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of July 21, 2010 (75 FR 42455). 
The document withdrew approval of 27 new drug applications (NDAs) and 
58 abbreviated new drug applications (ANDAs) from multiple applicants. 
The published document excluded a footnote in the table. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208, 
Silver Spring, MD 20993-0002, 301-796-9148.

SUPPLEMENTARY INFORMATION: In FR Doc. 2010-17785, appearing on page 
42455, in the Federal Register of Wednesday, July 21, 2010, the 
following correction is made:
    1. On page 42456, in Table 1, under the ``Drug'' column, correct 
the entry for ``Proventil (albuterol USP) Inhalation Aerosol'' to read 
``Proventil (albuterol USP) Inhalation Aerosol \1\''.
    2. On page 42456, at the end of the table, add footnote number 1 to 
read:

    This product included an oral pressurized metered-dose inhaler 
that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may 
no longer be used as a propellant for any albuterol metered-dose 
inhalers. (See 70 FR 17168, April 4, 2005.)

    Dated: September 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24400 Filed 9-22-11; 8:45 am]
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