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

---
identifier: "/us/fr/2011-24400"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2011-24400"
section_name: "Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction"
positive_law: false
currency: "2011-09-23"
last_updated: "2011-09-23"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2011-24400"
document_type: "notice"
publication_date: "2011-09-23"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "76 FR 59144"
fr_volume: 76
docket_ids:
  - "Docket No. FDA-2010-N-0318"
fr_action: "Notice; correction."
---


#  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 <sup>1</sup> ”.

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.