Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction, 106522 [2024-31307]

Download as PDF 106522 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices received (including those under review or on hold) until the publication date of this Federal Register document for transferred products and, if applicable, until a final decision on the submission is reached. For questions on any submissions with CDRH, please contact CDRH Product Jurisdiction at CDRHProductJurisdiction@fda.hhs.gov. For questions on submissions to CBER, please contact CBERProductJurisdiction@fda.hhs.gov. Dated: December 20, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024–31266 Filed 12–27–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–3248] Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 29, 2024. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 28, 2024. The document indicated that FDA was withdrawing approval of the ANDAs 073462 for tolmetin sodium capsules, equivalent to (EQ) 400 milligrams (mg) base; 073588 for tolmetin sodium tablets, EQ 200 mg base; 074002 for tolmetin sodium tablets, EQ 600 mg base; 077040 for citalopram hydrobromide tablets, EQ 10 mg base, EQ 20 mg base; EQ 40 mg base; 085787 for trifluoperazine hydrochloride (HCl) concentrate, EQ 10 mg base/milliliters (mL); 086808 for cyproheptadine HCl tablets, 4 mg; 087774 for phenylbutazone capsules, 100 mg; and 088602 for pseudoephedrine HCl; triprolidine HCl tablets, 60 mg/2.5.mg, held by Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204, Princeton, NJ 08540. Additionally, ANDAS 075631 for ketorolac tromethamine injectable, 15 mg/mL and 30 mg/mL; 076427 for milrinone lactate injectable, EQ 1 mg base/mL; 076791 for haloperidol lactate injectable, EQ 5 mg base/mL; 076828 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 haloperidol lactate injectable, EQ 5 mg base/mL; 077947 for fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400 mg/200 mL (2 mg/mL); 078197 for granisetron HCl injectable, EQ 0.1 mg base/mL (EQ 0.1 mg base/mL); 091436 for levofloxacin injectable, EQ 500 mg/20 mL (EQ 25 mg/mL); 207101 for sumatriptan succinate injectable, EQ 6 mg base/0.5 mL (EQ12 mg base/mL); and 215065 for methocarbamol solution, 1gram/10 mL (100 mg/mL), held by Baxter Healthcare Corp., One Baxter Parkway, Deerfield, IL 60015; and the ANDAs 090367 for levofloxacin tablets, 250 mg, 500 mg, 750 mg; and 211959 for clobazam tablets, 10 mg and 20 mg, held by Celltrion USA, Inc., U.S. Agent for Celltrion, Inc., One Evertrust Plaza, Suite 1207, Jersey City, NJ 07302; and the ANDA 212053 for chlorzoxazone tablet, 375 mg and 750 mg, held by i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974. Before FDA withdrew the approval of these ANDAs, Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals, LLC, timely requested that approval of their respective ANDAs not be withdrawn, the approvals are still in effect. This notice corrects these errors. 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, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, July 29, 2024 (89 FR 60902), appearing on page 60902 in FR Doc. 2024–16627, the following correction is made: On page 60902, in the table, the entries for ANDA 073462, ANDA 073588, ANDA 074002, ANDA 075631, ANDA 076427, ANDA 076791, ANDA 076828, ANDA 077040, ANDA 077947, ANDA 078197, ANDA 085787, ANDA 086808, ANDA 087774, ANDA 088602, ANDA 090367, ANDA 091436 ANDA 207101, ANDA 211959, ANDA 212053, and ANDA 215065 are removed. Dated: December 20, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024–31307 Filed 12–27–24; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Update to the Health Resources and Services Administration-Supported Women’s Preventive Services Guidelines Health Resources and Services Administration (HRSA), Department of Health and Human Services. AGENCY: ACTION: Notice. The Health Resources and Services Administration (HRSA) published a Federal Register Notice on October 22, 2024, with proposed updates to the HRSA-supported Women’s Preventive Services Guidelines (Guidelines). The proposed updates specifically relate to recommendations for Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation Services for Breast and Cervical Cancer Screening. Recommendations to update the Guidelines are developed by the Women’s Preventive Services Initiative (WPSI) for consideration by HRSA. WPSI convenes expert health professionals to conduct rigorous reviews of the evidence following the National Academy of Medicine standards for establishing foundations for and rating strengths of recommendations, articulation of recommendations, and external reviews and it develops draft recommendations for HRSA’s consideration. After consideration of public comment, HRSA has accepted the recommendations as revised and detailed in this notice. Under applicable law, nongrandfathered group health plans and health insurance issuers offering nongrandfathered group and individual health insurance coverage must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSAsupported Guidelines. The Departments of Labor, Health and Human Services, and the Treasury have previously issued regulations describing how group health plans and health insurance issuers apply the coverage requirements. Please see https://www.hrsa.gov/womensguidelines for additional information. SUMMARY: FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and Child Health Bureau, telephone: (301) 443–2170, email: wellwomancare@ hrsa.gov. E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Page 106522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3248]


Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 
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 on July 29, 2024. The document 
announced the withdrawal of approval of 23 abbreviated new drug 
applications (ANDAs) from multiple applicants, withdrawn as of August 
28, 2024. The document indicated that FDA was withdrawing approval of 
the ANDAs 073462 for tolmetin sodium capsules, equivalent to (EQ) 400 
milligrams (mg) base; 073588 for tolmetin sodium tablets, EQ 200 mg 
base; 074002 for tolmetin sodium tablets, EQ 600 mg base; 077040 for 
citalopram hydrobromide tablets, EQ 10 mg base, EQ 20 mg base; EQ 40 mg 
base; 085787 for trifluoperazine hydrochloride (HCl) concentrate, EQ 10 
mg base/milliliters (mL); 086808 for cyproheptadine HCl tablets, 4 mg; 
087774 for phenylbutazone capsules, 100 mg; and 088602 for 
pseudoephedrine HCl; triprolidine HCl tablets, 60 mg/2.5.mg, held by 
Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204, Princeton, NJ 
08540. Additionally, ANDAS 075631 for ketorolac tromethamine 
injectable, 15 mg/mL and 30 mg/mL; 076427 for milrinone lactate 
injectable, EQ 1 mg base/mL; 076791 for haloperidol lactate injectable, 
EQ 5 mg base/mL; 076828 haloperidol lactate injectable, EQ 5 mg base/
mL; 077947 for fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400 
mg/200 mL (2 mg/mL); 078197 for granisetron HCl injectable, EQ 0.1 mg 
base/mL (EQ 0.1 mg base/mL); 091436 for levofloxacin injectable, EQ 500 
mg/20 mL (EQ 25 mg/mL); 207101 for sumatriptan succinate injectable, EQ 
6 mg base/0.5 mL (EQ12 mg base/mL); and 215065 for methocarbamol 
solution, 1gram/10 mL (100 mg/mL), held by Baxter Healthcare Corp., One 
Baxter Parkway, Deerfield, IL 60015; and the ANDAs 090367 for 
levofloxacin tablets, 250 mg, 500 mg, 750 mg; and 211959 for clobazam 
tablets, 10 mg and 20 mg, held by Celltrion USA, Inc., U.S. Agent for 
Celltrion, Inc., One Evertrust Plaza, Suite 1207, Jersey City, NJ 
07302; and the ANDA 212053 for chlorzoxazone tablet, 375 mg and 750 mg, 
held by i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974. 
Before FDA withdrew the approval of these ANDAs, Fosun Pharma USA Inc.; 
Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, 
Inc.; and i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974, 
informed FDA that they did not want the approval of the ANDAs 
withdrawn. Because Fosun Pharma USA Inc.; Baxter Healthcare Corp.; 
Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 
Pharmaceuticals, LLC, timely requested that approval of their 
respective ANDAs not be withdrawn, the approvals are still in effect. 
This notice corrects these errors.

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, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, July 29, 
2024 (89 FR 60902), appearing on page 60902 in FR Doc. 2024-16627, the 
following correction is made:
    On page 60902, in the table, the entries for ANDA 073462, ANDA 
073588, ANDA 074002, ANDA 075631, ANDA 076427, ANDA 076791, ANDA 
076828, ANDA 077040, ANDA 077947, ANDA 078197, ANDA 085787, ANDA 
086808, ANDA 087774, ANDA 088602, ANDA 090367, ANDA 091436 ANDA 207101, 
ANDA 211959, ANDA 212053, and ANDA 215065 are removed.

    Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31307 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P

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