Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications; Correction
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on December 18, 2023. The document announced the withdrawal of approval of two new drug applications (NDA), withdrawn as of January 17, 2024. The document indicated that FDA was withdrawing approval of NDA 022424, FLOWTUSS (guaifenesin 200 milligrams (mg)/5 milliliters (mL) and hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution held by Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920. Before FDA withdrew the approval of this NDA, Chartwell RX Sciences, LLC informed FDA that it did not want the approval of the NDA withdrawn. Because Chartwell RX Sciences, LLC timely requested that approval of NDA 022424 not be withdrawn, the approval is still in effect. This notice corrects that error.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 51 (Thursday, March 14, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Notices]
[Page 18641]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5323]
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two
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 on December 18, 2023. The
document announced the withdrawal of approval of two new drug
applications (NDA), withdrawn as of January 17, 2024. The document
indicated that FDA was withdrawing approval of NDA 022424, FLOWTUSS
(guaifenesin 200 milligrams (mg)/5 milliliters (mL) and hydrocodone
bitartrate 2.5 mg/5 mL) Oral Solution held by Chartwell RX Sciences,
LLC, 77 Brenner Dr., Congers, NY 10920. Before FDA withdrew the
approval of this NDA, Chartwell RX Sciences, LLC informed FDA that it
did not want the approval of the NDA withdrawn. Because Chartwell RX
Sciences, LLC timely requested that approval of NDA 022424 not be
withdrawn, the approval is still in effect. This notice corrects that
error.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#d49fbdb9b6b1a6b8adfa98b1bca6b2b1b8b094b2b0b5fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="b9f2d0d4dbdccbd5c097f5dcd1cbdfdcd5ddf9dfddd897d1d1ca97ded6cf">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, December
18, 2023 (88 FR 87433), appearing on page 87433 in FR Doc. 2023-27661,
the following correction is made:
On page 87433, in the table, the entry for NDA 022424 is removed.
Dated: March 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05426 Filed 3-13-24; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.