Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat), 68909 [2024-19334]

Download as PDF Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices email at least 2 days prior to the meeting with information on how to access the virtual platform that will host the virtual breakout scenario discussions. Please note due to limited technology capacity, participation in the virtual breakout scenario discussions will be limited to 150 participants. Once capacity reaches 150 participants, the breakout session will be closed to additional participants. Additional information regarding the virtual breakout scenario discussions will be provided at https://www.fdalive.com/ peac. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 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The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: August 23, 2024. Lauren K. Roth, Associate Commissioner for Policy. khammond on DSKJM1Z7X2PROD with NOTICES [FR Doc. 2024–19323 Filed 8–27–24; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:13 Aug 27, 2024 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that LIVMARLI (maralixibat), manufactured by Mirum Pharmaceuticals, Inc., meets the criteria for a priority review voucher. LIVMARLI (maralixibat) oral solution is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDisease PriorityVoucherProgram/default.htm. For further information about LIVMARLI (maralixibat), go to the ‘‘Drugs@FDA’’ website at https:// SUPPLEMENTARY INFORMATION: Frm 00061 Fmt 4703 www.accessdata.fda.gov/scripts/cder/ daf/. Dated: August 23, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–19334 Filed 8–27–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that LIVMARLI (maralixibat), approved on September 29, 2021, manufactured by Mirum Pharmaceuticals, Inc., meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1394, Cathryn.Lee@ fda.hhs.gov. SUMMARY: PO 00000 68909 Sfmt 4703 [Docket No. FDA–2024–P–0805] Determination That FENTANYL CITRATE Injections, Equivalent to 2.5 Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100 Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that FENTANYL CITRATE Injections, equivalent to 2.5 milligram (mg) base/50 milliliter (mL) (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for FENTANYL CITRATE Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Swati Rawani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993–0002, 240– 402–9917, Swati.Rawani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved; and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain SUMMARY: E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Page 68909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19334]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product; LIVMARLI (maralixibat)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of a priority review voucher to the sponsor of a rare 
pediatric disease product application. The Federal Food, Drug, and 
Cosmetic Act (FD&C Act) authorizes FDA to award priority review 
vouchers to sponsors of approved rare pediatric disease product 
applications that meet certain criteria. FDA is required to publish 
notice of the award of the priority review voucher. FDA has determined 
that LIVMARLI (maralixibat), approved on September 29, 2021, 
manufactured by Mirum Pharmaceuticals, Inc., meets the criteria for a 
priority review voucher.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority 
review voucher to the sponsor of an approved rare pediatric disease 
product application. Under section 529 of the FD&C Act (21 U.S.C. 
360ff), FDA will award priority review vouchers to sponsors of approved 
rare pediatric disease product applications that meet certain criteria. 
FDA has determined that LIVMARLI (maralixibat), manufactured by Mirum 
Pharmaceuticals, Inc., meets the criteria for a priority review 
voucher. LIVMARLI (maralixibat) oral solution is indicated for the 
treatment of cholestatic pruritus in patients with Alagille syndrome 
(ALGS) 1 year of age and older.
    For further information about the Rare Pediatric Disease Priority 
Review Voucher Program and for a link to the full text of section 529 
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about LIVMARLI (maralixibat), go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19334 Filed 8-27-24; 8:45 am]
BILLING CODE 4164-01-P

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