49032 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

product. Although only a portion of a 

regulatory review period may count 

toward the 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 biological 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 biologic product OBIZUR 

(rpFVIII). OBIZUR is indicated for the 

treatment of bleeding episodes in adults 

with acquired hemophilia A. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for OBIZUR (U.S. Patent 

Nos. 6,180,371; 6,458,563; and 

7,560,107) from Emory University and 

(U.S. Patent No. 7,576,181) from Emory 

University, Baxter International, Inc., 

and Baxter Healthcare SA; and the 

USPTO requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In letters dated 

October 19, 2015, and January 11, 2016, 

FDA advised the USPTO that this 

human biological product had 

undergone a regulatory review period 

and that the approval of OBIZUR 

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 

OBIZUR is 4,216 days. Of this time, 

3,883 days occurred during the testing 

phase of the regulatory review period, 

while 333 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 (21 U.S.C. 355(i)) 

became effective: April 10, 2003. The 

applicant claims May 27, 2003, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was April 10, 2003. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): November 25, 2013. The 

applicant claims October 10, 2013, as 

the date the biologics license 

application (BLA) for OBIZUR (BLA 

125512/0) was initially submitted. 

However, FDA records indicate that 

BLA 125512/0 was submitted on 

November 25, 2013. 

3. The date the application was 

approved: October 23, 2014. FDA has 

verified the applicant’s claim that BLA 

125512/0 was approved on October 23, 

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 applications for patent extension, 

this applicant seeks 5 years 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: October 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22898 Filed 10–20–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–3581] 

Determination That ELAVIL 

(Amitriptyline Hydrochloride) Oral 

Tablets, 10, 25, 50, 75, 100, and 150 

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 ELAVIL (amitriptyline 

hydrochloride) oral tablets, 10 

milligrams (mg), 25 mg, 50 mg, 75 mg, 

100 mg, and 150 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for amitriptyline 

hydrochloride oral tablets, 10 mg, 25 

mg, 50 mg, 75 mg, 100 mg, and 150 mg, 

if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

stacy.kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49033 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

ELAVIL (amitriptyline hydrochloride) 

oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 

100 mg, and 150 mg, are the subject of 

NDA 012703, held by AstraZeneca, and 

initially approved on April 7, 1961. 

ELAVIL is indicated for the relief of 

symptoms of depression. ELAVIL 

(amitriptyline hydrochloride) oral 

tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 

mg, and 150 mg, are currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. In the 

Federal Register of June 16, 2006 (71 FR 

34940), FDA announced that it was 

withdrawing approval of NDA 012703, 

effective June 16, 2006. 

Alembic Pharmaceuticals Limited 

submitted a citizen petition dated June 

5, 2017 (Docket No. FDA–2017–P– 

3581), under 21 CFR 10.30, requesting 

that the Agency determine whether 

ELAVIL (amitriptyline hydrochloride) 

oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 

100 mg, and 150 mg, were withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that ELAVIL (amitriptyline 

hydrochloride) oral tablets, 10 mg, 25 

mg, 50 mg, 75 mg, 100 mg, and 150 mg, 

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that these 

products were withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of ELAVIL 

(amitriptyline hydrochloride) oral 

tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 

mg, and 150 mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ELAVIL (amitriptyline 

hydrochloride) oral tablets, 10 mg, 25 

mg, 50 mg, 75 mg, 100 mg, and 150 mg, 

in the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to ELAVIL (amitriptyline hydrochloride) 

oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 

100 mg, and 150 mg, may be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: October 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22892 Filed 10–20–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidance for 

Methylphenidate Hydrochloride; New 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

new draft guidance for industry on 

generic methylphenidate hydrochloride 

oral extended-release tablets entitled 

‘‘Draft Guidance on Methylphenidate 

Hydrochloride.’’ The new draft 

guidance, when finalized, will provide 

product-specific recommendations on, 

among other things, the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for methylphenidate 

hydrochloride oral extended-release 

tablets. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 22, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 

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 else’s 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 (HFA–305), 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 


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