Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2455 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product DAKLINZA 

(daclatasvir dihydrochloride). 

DAKLINZA is indicated for use with 

sofosbuvir for the treatment of chronic 

HCV genotype 3 infection. Subsequent 

to this approval, the USPTO received a 

patent term restoration application for 

DAKLINZA (U.S. Patent No. 8,329,159) 

from Bristol-Myers Squibb Company, 

and the USPTO requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated July 12, 2016, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of DAKLINZA represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

USPTO requested that FDA determine 

the product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

DAKLINZA is 2,808 days. Of this time, 

2,327 days occurred during the testing 

phase of the regulatory review period, 

while 481 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under section 

505(i) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

355(i)) became effective: November 17, 2007. 

The applicant claims November 16, 2007, as 

the date the investigational new drug 

application (IND) became effective. However, 

FDA records indicate that the IND effective 

date was November 17, 2007, which was 30 

days after FDA receipt of the IND. 

2. The date the application was initially 

submitted with respect to the human drug 

product under section 505(b) of the FD&C 

Act: March 31, 2014. FDA has verified the 

applicant’s claim that the new drug 

application (NDA) for DAKLINZA (NDA 

206843) was initially submitted on March 31, 

2014. 

3. The date the application was approved: 

July 24, 2015. FDA has verified the 

applicant’s claim that NDA 206843 was 

approved on July 24, 2015. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 467 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00675 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0002] 

Delcor Asset Corp. et al.; Withdrawal 

of Approval of 22 Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 22 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The holders of the 

applications 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 

February 16, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945, 

Trang.Tran@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in 

table 1 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 § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL

Application No. Drug Applicant 

ANDA 060577 .......... Mycostatin (nystatin) Vaginal Tablets, 100,000 units ........... Delcor Asset Corp., 411 South State St., Suite E–100, 

Newtown, PA 18940. 

ANDA 063302 .......... Cefamandole Nafate for Injection ......................................... ACS Dobfar SpA, c/o Interchem Corp., 120 Route 17 

North, Paramus, NJ 07653. 

ANDA 070462 .......... Diazepam Tablets USP, 2 milligrams (mg) .......................... Virtus Pharmaceuticals, 12 Penns Trail, Newtown, PA 

18940. 

ANDA 070463 .......... Diazepam Tablets USP, 5 mg .............................................. Do. 

ANDA 070998 .......... Potassium Chloride Extended-Release Tablets, 8 milliequivalents (mEq).Future Pak, Ltd., 28115 Lakeview Dr., Wixom, MI 48393. 

ANDA 070999 .......... Potassium Chloride Extended-Release Tablets, 10 mEq .... Do. 


ethrower on DSK3G9T082PROD with NOTICES
2456 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 

TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL—Continued 

Application No. Drug Applicant 

ANDA 075375 .......... Diltiazem Hydrochloride (HCl) Injection, 5 mg/milliliter (mL) Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc., 

781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, 

WV 26504. 

ANDA 076911 .......... Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, 

and 15 mg.

Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, 

NJ 08540. 

ANDA 077102 .......... Calcitriol Injection, 0.001 mg/mL ........................................... Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd., Suite 

450, Schaumburg, IL 60195. 

ANDA 084656 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, 

OH 43228. 

ANDA 087977 .......... Diphenhydramine HCl Capsules, 25 mg .............................. LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY 

11788. 

ANDA 088676 .......... Methylprednisolone Sodium Succinate for Injection USP, 

Equivalent to 40 mg base/vial.

LyphoMed, Division of Fujisawa USA, Inc., 2045 North 

Cornell Ave., Melrose Park, IL 60160. 

ANDA 089080 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, 

NJ 07207. 

ANDA 089183 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/15 mg.

Superpharm Corp., 1769 Fifth Ave., Bayshore, NY 11706. 

ANDA 089253 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Do. 

ANDA 089219 .......... Procainamide HCl Capsules USP, 250 mg, 375 mg, and 

500 mg.

IDT Australia, Ltd., c/o Facet Life Sciences, Inc., 6122 

Stone Wolfe Dr., Glen Carbon, IL 62034. 

ANDA 089254 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/60 mg.

Do. 

ANDA 089369 .......... Procainamide HCl Extended-Release Tablets USP, 250 

mg, 500 mg, and 750 mg.

Do. 

ANDA 089481 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/15 mg.

American Therapeutics, Inc., 75 Carlough Rd., Bohemia, 

NY 11716. 

ANDA 089482 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Do. 

ANDA 089483 .......... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/60 mg.

Do. 

ANDA 206711 .......... Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 

mg, and 20 mg.

Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., One 

Grande Commons, 440 U.S. Highway 22 East, Suite 

150, Bridgewater, NJ 08807. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 16, 

2018. Introduction or delivery for 

introduction into interstate commerce of 

products without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in table 1 

that are in inventory on the date that 

this notice becomes effective (see the 

DATES section) 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: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00695 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0155] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Veterinary Feed 

Directive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of our veterinary 

feed directive (VFD) regulation. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 19, 2018. 

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 March 19, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 2018. 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://

www.regulations.gov will be posted to 


ethrower on DSK3G9T082PROD with NOTICES