Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction
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Abstract
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 20, 2026. The document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 23, 2026. The document indicated that FDA was withdrawing approval of ANDAs 078022 for propranolol hydrochloride (HCl), extended- release capsule, 60 milligrams (mg), 80 mg, 120 mg, and 160 mg, and 090665 for lidocaine HCl, injectable, 2%, held by Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, 2255 Glades Rd., Suite 324A, Boca Raton, FL 33431. Before FDA withdrew the approval of these ANDAs, Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, timely requested that approval of their ANDAs not be withdrawn, the approvals are still in effect. This notice corrects that error.
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<title>Federal Register, Volume 91 Issue 115 (Tuesday, June 16, 2026)</title>
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[Federal Register Volume 91, Number 115 (Tuesday, June 16, 2026)]
[Notices]
[Pages 36145-36146]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-12044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1224]
Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.;
Withdrawal of Approval of 11 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 on February 20, 2026. The
document announced the withdrawal of approval of 11 abbreviated new
drug applications (ANDAs) from multiple applicants, withdrawn as of
March 23, 2026. The document indicated that FDA was withdrawing
approval of ANDAs 078022 for propranolol hydrochloride (HCl), extended-
release capsule, 60 milligrams (mg), 80 mg, 120 mg, and 160 mg, and
090665 for lidocaine HCl, injectable, 2%, held by Masuu Global
Solutions LLC, U.S. Agent for Extrovis
[[Page 36146]]
AG, 2255 Glades Rd., Suite 324A, Boca Raton, FL 33431. Before FDA
withdrew the approval of these ANDAs, Masuu Global Solutions LLC, U.S.
Agent for Extrovis AG, informed FDA that they did not want the approval
of the ANDAs withdrawn. Because Masuu Global Solutions LLC, U.S. Agent
for Extrovis AG, timely requested that approval of their ANDAs not be
withdrawn, the approvals are still in effect. This notice corrects that
error.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, <a href="/cdn-cgi/l/email-protection#4b062a393f232a65052c3e322e250b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="612c00131509004f2f061418040f210705004f0909124f060e17">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, February
20, 2026 (91 FR 8242), appearing on page 8242 in FR Doc. 2026-03411,
the following correction is made:
On page 8243, in the table, the entries for ANDA 078022 and ANDA
090665 are removed.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-12044 Filed 6-15-26; 8:45 am]
BILLING CODE 4164-01-P
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