Allergan Pharmaceuticals International, Ltd.; Withdrawal of Approval of a New Drug Application for ASACOL (Mesalamine) Delayed-Release Tablets, 400 Milligrams, 79491 [2020-27082]

Download as PDF Federal Register / Vol. 85, No. 238 / Thursday, December 10, 2020 / Notices Ming Marine Transport Corp.; Zim Integrated Shipping Services, Ltd.; and Matson Navigation Company, Inc. Filing Party: Robert Magovern; Cozen O’Connor. Synopsis: The Amendment adds Matson Navigation Company, Inc. as a party to the Agreement. Proposed Effective Date: 1/15/2021. Location: https://www2.fmc.gov/ FMC.Agreements.Web/Public/ AgreementHistory/34503. Dated: December 4, 2020. Rachel E. Dickon, Secretary. [FR Doc. 2020–27067 Filed 12–9–20; 8:45 am] BILLING CODE 6730–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–2196] Allergan Pharmaceuticals International, Ltd.; Withdrawal of Approval of a New Drug Application for ASACOL (Mesalamine) DelayedRelease Tablets, 400 Milligrams AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ASACOL (mesalamine) delayed-release tablets, 400 milligrams (mg), held by Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612 (Allergan). Pursuant to FDA’s request, Allergan agreed to withdrawal of this application and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of December 10, 2020. 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, Kimberly.Lehrfeld@ fda.hhs.gov. SUMMARY: On January 31, 1992, FDA approved NDA 019651 for ASACOL (mesalamine) delayed-release tablets, 400 mg. It is approved for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older, and for the maintenance of remission of mildly to moderately active UC in adults. In December 2012, FDA jbell on DSKJLSW7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:36 Dec 09, 2020 Jkt 253001 published the guidance for industry ‘‘Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products,’’ available at https:// www.fda.gov/media/83029/download, describing evidence that certain phthalate esters (phthalates), including dibutyl phthalate (DBP) and di(2ethylhexyl) phthalate from pharmaceutical products, are developmental and reproductive toxicants in laboratory animals. This evidence has raised concerns about human exposure to phthalates, particularly in vulnerable populations such as pregnant women and infants. ASACOL (mesalamine) delayed-release tablets, 400 mg, contain DBP as an inactive ingredient. On September 6, 2017, FDA notified Allergen that because ASACOL (mesalamine) delayed-release tablets, 400 mg, contains DBP, the product presents a potential problem that is sufficiently serious to warrant withdrawal of approval. On December 22, 2017, Allergan agreed to have FDA withdraw approval of NDA 019651 for ASACOL (mesalamine) delayed-release tablets, 400 mg, under § 314.150(d) (21 CFR 314.150(d)) and waived its opportunity for a hearing. For the reasons discussed above, and pursuant to the applicant’s agreement, approval of NDA 019651 for ASACOL (mesalamine) delayed-release tablets, 400 mg, and all amendments and supplements thereto, is withdrawn under § 314.150(d). Distribution of ASACOL (mesalamine) delayed-release tablets, 400 mg, into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Dated: December 4, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–27082 Filed 12–9–20; 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 names of the members who will serve on its fiscal year (FY) 2020 Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of Senior Executive Service (SES), Senior Professional, 21st Century Cures Act, and Title 42(f) (SES Equivalents) performance appraisals, bonus recommendations, and pay adjustments. SUMMARY: DATES: Approved October 1, 2020. Abu Sesay, Office of Human Capital Management (OHCM), Three White Flint North, 02C47, 11601 Landsdown St., North Bethesda, MD 20852, Office Number: 240–402–0440 (not a toll-free number). FOR FURTHER INFORMATION CONTACT: This action is being taken pursuant to 5 U.S.C. 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register. The following persons will serve on the FDA FY 2020 Performance Review Board, which oversees the evaluation of performance appraisals of FDA’s Senior Executives and Equivalents: SUPPLEMENTARY INFORMATION: • • • • • • • • • • • James Sigg, PRB Chair Tania Tse, PRB Officiator Glenda Barfell Janelle Barth Vincent Bunning Mary Beth Clarke Elizabeth Dickinson Tracey Forfa Denise Huttenlocker Diane Maloney William Tootle Dated: December 4, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–27123 Filed 12–9–20; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2020–N–2227] Food and Drug Administration Fiscal Year 2020 Performance Review Board AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00031 Fmt 4703 Sfmt 9990 79491 E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 85, Number 238 (Thursday, December 10, 2020)]
[Notices]
[Page 79491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2196]


Allergan Pharmaceuticals International, Ltd.; Withdrawal of 
Approval of a New Drug Application for ASACOL (Mesalamine) Delayed-
Release Tablets, 400 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
approval of the new drug application (NDA) for ASACOL (mesalamine) 
delayed-release tablets, 400 milligrams (mg), held by Allergan 
Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 
Dupont Dr., Irvine, CA 92612 (Allergan). Pursuant to FDA's request, 
Allergan agreed to withdrawal of this application and has waived its 
opportunity for a hearing.

DATES: Approval is withdrawn as of December 10, 2020.

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, [email protected].

SUPPLEMENTARY INFORMATION: On January 31, 1992, FDA approved NDA 019651 
for ASACOL (mesalamine) delayed-release tablets, 400 mg. It is approved 
for the treatment of mildly to moderately active ulcerative colitis 
(UC) in patients 5 years of age and older, and for the maintenance of 
remission of mildly to moderately active UC in adults. In December 
2012, FDA published the guidance for industry ``Limiting the Use of 
Certain Phthalates as Excipients in CDER-Regulated Products,'' 
available at https://www.fda.gov/media/83029/download, describing 
evidence that certain phthalate esters (phthalates), including dibutyl 
phthalate (DBP) and di(2-ethylhexyl) phthalate from pharmaceutical 
products, are developmental and reproductive toxicants in laboratory 
animals. This evidence has raised concerns about human exposure to 
phthalates, particularly in vulnerable populations such as pregnant 
women and infants. ASACOL (mesalamine) delayed-release tablets, 400 mg, 
contain DBP as an inactive ingredient. On September 6, 2017, FDA 
notified Allergen that because ASACOL (mesalamine) delayed-release 
tablets, 400 mg, contains DBP, the product presents a potential problem 
that is sufficiently serious to warrant withdrawal of approval. On 
December 22, 2017, Allergan agreed to have FDA withdraw approval of NDA 
019651 for ASACOL (mesalamine) delayed-release tablets, 400 mg, under 
Sec.  314.150(d) (21 CFR 314.150(d)) and waived its opportunity for a 
hearing.
    For the reasons discussed above, and pursuant to the applicant's 
agreement, approval of NDA 019651 for ASACOL (mesalamine) delayed-
release tablets, 400 mg, and all amendments and supplements thereto, is 
withdrawn under Sec.  314.150(d).
    Distribution of ASACOL (mesalamine) delayed-release tablets, 400 
mg, into interstate commerce without an approved application is illegal 
and subject to regulatory action (see sections 505(a) and 301(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

    Dated: December 4, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27082 Filed 12-9-20; 8:45 am]
BILLING CODE 4164-01-P

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