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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices
Application No.

Drug
NDA 020509

Gemzar gemcitabine HCl Injection, EQ 200 mg base and EQ 1 gram g base.
Antizol fomepizole Injection, 1.5 g/1.5 mL

NDA 020696
NDA 020705
NDA 021114
NDA 021199
NDA 021571
NDA 050704
NDA 204736
NDA 205060
NDA 206843

Rescriptor delavirdine mesylate Tablets, 100 mg and 200
mg.
Betaxon levobetaxolol HCl Ophthalmic Suspension, EQ
0.5% base.
Quixin levofloxacin Ophthalmic Solution, 0.5%
Iquix levofloxacin Ophthalmic Solution, 1.5%
DaunoXome daunorubicin citrate liposome injection, EQ 2
mg base/mL.
AcipHex Sprinkle rabeprazole sodium Delayed Release Capsules, 5 mg and 10 mg.
Epanova omega-3-carboxylic acids Capsules, 1 gram 1 g contains at least 850 mg of polyunsaturated fatty acids.
Daklinza daclatasvir dihydrochloride Tablets, EQ 30 mg base, EQ 60 mg base, and EQ 90 mg base.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 1, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301a and d of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 331a and d.
Drug products that are listed in the table that are in inventory on December 1, 2021 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Dated: October 25, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202123729 Filed 102921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket Nos. FDA2020E1817; FDA
2020E1818; FDA2020E1820

lotter on DSK11XQN23PROD with NOTICES1

Determination of Regulatory Review Period for Purposes of Patent Extension; ENHERTU
AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for ENHERTU and is publishing this
SUMMARY:

VerDate Sep<11>2014

Applicant
18:03 Oct 29, 2021

Jkt 256001

Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Par Sterile Products, LLC, 6 Ram Ridge Rd., Chestnut Ridge, NY 10977.
ViiV Healthcare Co., 5 Moore Dr., Research Triangle Park, NC 27709.
Alcon Laboratories, Inc.
Santen Inc., 6401 Hollis St., Suite 125, Emeryville, CA
94608.
Do.
Galen Limited, 25 Fretz Rd., Souderton, PA 18964.
Aytu BioScience Inc., 373 Inverness Parkway, Suite 206, Englewood, CO 80112.
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
Bristol-Myers Squibb Co.

notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office USPTO, Department of Commerce, for the extension of a patent which claims that human biological product.
DATES: Anyone with knowledge that any of the dates as published see SUPPLEMENTARY INFORMATION are incorrect may submit either electronic or written comments and ask for a redetermination by January 3, 2022.
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 2, 2022. See Petitions in the SUPPLEMENTARY INFORMATION section for more information.
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 3, 2022. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 3, 2022. Comments received by mail/hand delivery/courier for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Electronic Submissions Submit electronic comments in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
Comments submitted electronically, including attachments, to https

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www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone elses Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https www.regulations.gov.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed see Written/Paper Submissions and Instructions.
Written/Paper Submissions Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions.
Instructions: All submissions received must include the Docket Nos. FDA
2020E1817; FDA2020E1818; and FDA2020E1820, for Determination of Regulatory Review Period for Purposes of Patent Extension;
ENHERTU. Received comments, those filed in a timely manner see
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01NON1