2011-24400. 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.

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.