Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices marketed in accordance with requirements under section 505G of the FD&C Act 21 U.S.C. 355h, often referred to as over-the-counter monograph drugs, and animal drug products that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act 21 U.S.C. 360b, 360ccc, and 360ccc1.
This draft guidance is being issued consistent with FDAs good guidance practices regulation 21 CFR 10.115.
The draft guidance, when finalized, will represent the current thinking of FDA
on Reporting Amount of Listed Drugs and Biological Products Under Section 510j3 of the FD&C Act. It does not establish any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

compound, or process. Registrants must submit information on the following listed drugs: 1 Finished dosage form products, 2 drug products with active pharmaceutical ingredients, and 3
other listed drugs. The collection of information under section 510j3 of the FD&C Act as added by section 3112
of the CARES Act on the amount of listed drug products has been approved under OMB control number 09100045.
FDA is developing an electronic portal for registrants to submit this information.
FDA requires that applicants submit annual reports for abbreviated new drug applications, biologics license applications, and new drug applications. The collections of information in parts 314 and 601 have been approved under OMB control numbers 09100001 and 09100338.

II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA.
The regulatory citations and associated collections of information that OMB approved are as follows:
Registrants who own or operate a domestic or foreign establishment that manufactures, prepares, propagates, compounds, or processes a drug must submit to FDA information on the amount of listed drugs that they manufacture, prepare, propagate,
III. Electronic Access
Dated: October 27, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202123722 Filed 102921; 8:45 am BILLING CODE 416401P

Application No.

Drug
NDA 007409

NDA 014169

Bentyl dicyclomine hydrochloride HCl Capsules, 10 milligram mg.
Bentyl dicyclomine HCl Tablets, 20 mg.
Norinyl 1 + 50 norethindrone and mestranol Tablets, 0.05
mg/1 mg.
Norinyl norethindrone and mestranol Tablets, 0.1 mg/2 mg Dendrid idoxuridine Ophthalmic Solution, 0.1%

NDA 019404
NDA 019784

Ocufen flurbiprofen sodium Ophthalmic Solution, 0.03%
Ibuprofen Oral Suspension, 100 mg/5 milliliters mL

NDA 020010

Lotrisone betamethasone dipropionate and clotrimazole Lotion, Equivalent to EQ 0.05% base/1%.

NDA 020098

Mivacron mivacurium chloride Solution, EQ 2 mg base/mL, EQ 10 mg base/5 mL, and EQ 20 mg base/10 mL.
Mivacron in Dextrose 5% in plastic container mivacurium chloride Injectable, EQ 0.5 mg base/mL and EQ 50 mg base/100 mL.
Zerit stavudine Capsules, 5 mg, 15 mg, 20 mg, 30 mg, and 40 mg.

NDA 013625

lotter on DSK11XQN23PROD with NOTICES1

Persons with access to the internet may obtain the draft guidance at https
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https
www.regulations.gov.

NDA 020412

VerDate Sep<11>2014

18:03 Oct 29, 2021

Jkt 256001

PO 00000

60251

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N1071

Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 New Drug Applications AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or Agency is withdrawing approval of 18 new drug applications NDAs from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of December 1, 2021.
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 209930002, 301
7963137.
SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in 314.150c 21 CFR 314.150c. The applicants have also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application under 314.150c is without prejudice to refiling.
SUMMARY:

Applicant
Frm 00054

Fmt 4703

Sfmt 4703

Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940.

Actavis Laboratories UT, Inc. an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., 145 Brandywine Pkwy., West Chester, PA 19380.
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134.
Allergan, Inc., 2525 Dupont Dr., Irvine, CA 92612.
Abbott Laboratories Established Pharmaceuticals Products Division, 200 Abbott Park Rd., Abbott Park, IL 60064.
Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., 1 Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889.
AbbVie, Inc., 1 N Waukegan Rd., North Chicago, IL 60064

Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543.

E:FRFM01NON1.SGM

01NON1