[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.

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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DATES: Approval is withdrawn as of December 10, 2020.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, Kimberly.Lehrfeld@fda.hhs.gov.

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


