2024-27082. Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2024-P-4163]

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 on October 16, 2024. The document announced that NOXAFIL (posaconazole) delayed-release tablets, 100 grams (g), was not withdrawn from sale for reasons of safety or effectiveness. The document incorrectly listed the dosage strength as 100 g. The correct strength is 100 milligrams (mg). This notice corrects that error.

FOR FURTHER INFORMATION CONTACT:

Awo Archampong-Gray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-796-0110, [e-mail].

SUPPLEMENTARY INFORMATION:

In FR Doc. 2024-23811, published in the Federal Register of Wednesday, October 16, 2024 (89 FR 83504), appearing on pages 83504 and 83505, the following corrections are made:

1. On page 83504, in the second column, the title of the document is corrected to read “Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.”

2. On page 83504, in the third column, in the SUMMARY , in the first paragraph, “NOXAFIL (posaconazole) delayed-release tablets, 100 grams (g),” is corrected to read “NOXAFIL (posaconazole) delayed-release tablets, 100 milligrams (mg),”.

3. On page 83505, in the first and second columns, all uses of “100 g” are corrected to read “100 mg”.

Dated: November 7, 2024.

Kimberlee Trzeciak,

Deputy Commissioner for Policy, Legislation, and International Affairs.