Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41273 

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: October 

26, 2009. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on October 26, 

2009. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: April 25, 2014. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

XTORO (NDA 206307) was initially 

submitted on April 25, 2014. 

3. The date the application was 

approved: December 17, 2014. FDA has 

verified the applicant’s claim that NDA 

206307 was approved on December 17, 

2014. 

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 1,058 days of patent 

term extension. 

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 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 21 

CFR 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with 21 CFR 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: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18379 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0002] 

Upsher-Smith Laboratories, Inc.; 

Withdrawal of Approval of an 

Abbreviated New Drug Application for 

PROPRANOLOL HYDROCHLORIDE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of an abbreviated 

new drug application (ANDA) for 

PROPRANOLOL HYDROCHLORIDE 

Extended-Release Capsules, held by 

Upsher-Smith Laboratories, Inc. 

(Upsher-Smith), 6701 Evenstad Dr., 

Maple Grove, MN 55369. Upsher-Smith 

has voluntarily requested that approval 

of this application be withdrawn and 

has waived its opportunity for a hearing. 

DATES: August 30, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Stefanie Kraus, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6215, 

Silver Spring, MD 20993–0002, 301– 

796–9585. 

SUPPLEMENTARY INFORMATION: On March 

6, 2009, FDA approved abbreviated new 

drug application (ANDA) 078311 for 

PROPRANOLOL HYDROCHLORIDE 

Extended-Release Capsules, USP, 60 

milligrams (mg), 80 mg, 120 mg, and 

160 mg. In a letter dated August 9, 2011, 

FDA informed Upsher-Smith that it had 

concerns about the validity of 

bioequivalence data submitted with 

ANDA 078311 from studies conducted 

by a certain contract research 

organization, establishing 

bioequivalence of Upsher-Smith’s 

product to the reference listed drug 

(RLD), INDERAL LA (propranolol 

hydrochloride) Extended Release 

Capsules, 60 mg, 80 mg, 120 mg, and 

160 mg. In that letter, FDA directed 

Upsher-Smith to supplement its ANDA 

with either: (1) New bioequivalence 

studies or (2) re-assays of the samples 

from the original bioequivalence 

studies. Upsher-Smith submitted new 

fasted and fed bioequivalence studies to 

supplement ANDA 078311 in paper 

format on August 29, 2013, and in 

electronic format on May 9, 2014. 

On April 14, 2016, FDA informed 

Upsher-Smith that the applicant’s fed 

bioequivalence study failed to meet 

FDA’s bioequivalence criteria and, 

therefore, requested that Upsher-Smith 

voluntarily seek withdrawal of ANDA 

078311 under § 314.150(d) (21 CFR 

314.150(d)). 

In a letter dated May 13, 2016, 

Upsher-Smith requested that FDA 

withdraw approval of ANDA 078311 for 

PROPRANOLOL HYDROCHLORIDE 

Extended-Release Capsules under 

§ 314.150(d) because the new 

bioequivalence data did not 

demonstrate therapeutic equivalence of 

its product to the RLD, INDERAL LA. In 

that letter, Upsher-Smith also waived 

any opportunity for a hearing otherwise 

provided under § 314.150(a). 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(e)) and 

§ 314.150(d), and under authority 

delegated by the Commissioner of Food 

and Drugs to the Director, Center for 

Drug Evaluation and Research, approval 

of ANDA 078311, and all amendments 

and supplements thereto, is withdrawn 

(see DATES). Distribution of this product 

in interstate commerce without an 

approved application is illegal and 

subject to regulatory action (see sections 

505(a) and 301(d) of the FD&C Act (21 

U.S.C. 355(a) and 331(d)). 

Dated: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18375 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–1461] 

Determination That CENESTIN 

(Estrogens, Conjugated Synthetic A) 

Tablets, 0.3 Milligrams, 0.45 Milligrams, 

0.625 Milligrams, 0.9 Milligrams, and 

1.25 Milligrams, Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that CENESTIN (estrogens, 

conjugated synthetic A) Tablets, 0.3 

milligrams (mg), 0.45 mg, 0.625 mg, 0.9 

mstockstill on DSK30JT082PROD with NOTICES