80_FR_54468 80 FR 54294 - Determination That GLUCAGON (Glucagon Hydrochloride) for Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10 Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

80 FR 54294 - Determination That GLUCAGON (Glucagon Hydrochloride) for Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10 Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 174 (September 9, 2015)

Page Range54294-54295
FR Document2015-22673

The Food and Drug Administration (FDA) has determined that GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1 milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, if all other legal and regulatory requirements are met.

Federal Register, Volume 80 Issue 174 (Wednesday, September 9, 2015) 
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54294-54295]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22673]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-P-0248]


Determination That GLUCAGON (Glucagon Hydrochloride) for 
Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10 
Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety 
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1 
milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new drug applications (ANDAs) for 
glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg 
base/vial, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6206, Silver Spring, MD 20993, 240-402-0979.

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 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).

[[Page 54295]]

    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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial 
and EQ 10 mg base/vial, is the subject of NDA 12-122 held by Eli Lilly, 
and initially approved onNovember 14, 1960. GLUCAGON is indicated for 
treatment of severe hypoglycemia and as a diagnostic aid in the 
radiologic examination of the stomach, duodenum, small bowel, and 
colon.
    Under NDA 12-122, GLUCAGON (glucagon hydrochloride) for injection, 
EQ 1 mg base/vial and EQ 10 mg base/vial, was produced from animal 
sources. On September 11, 1998, FDA approved Eli Lilly's NDA 20-928 for 
GLUCAGON (glucagon rDNA origin), 1mg/vial. Subsequently, Eli Lilly 
discontinued sales of animal-sourced GLUCAGON in 2002. In 2005, FDA 
moved animal-sourced GLUCAGON (glucagon hydrochloride) for injection, 
EQ 1 mg base/vial and EQ 10 mg base/vial, to the ``Discontinued Drug 
Product List'' section of the Orange Book.
    Walter G. Jump, on behalf of Cornerstone Regulatory, submitted a 
citizen petition dated August 7, 2007 (Docket No. FDA-2007-P-0248), 
under 21 CFR 10.30, requesting that the Agency determine whether 
animal-sourced GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg 
base/vial and EQ 10 mg base/vial, was withdrawn from sale for reasons 
of safety or effectiveness.
    After considering the citizen petition, reviewing Agency records, 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that GLUCAGON (glucagon hydrochloride) for 
injection, EQ 1 mg base/vial and EQ 10 mg base/vial, was not withdrawn 
for reasons of safety or effectiveness. The petitioner has identified 
no data or other information suggesting that GLUCAGON (glucagon 
hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, 
was withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal from sale of 
GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and 
EQ 10 mg base/vial. We have also independently evaluated relevant 
literature and data for possible postmarketing adverse events. We have 
reviewed the available evidence and determined that the product was not 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GLUCAGON (glucagon 
hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, 
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 GLUCAGON 
(glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg 
base/vial, may be approved by the Agency as long as they meet all other 
legal and regulatory requirements for the approval of ANDAs. However, 
it is the Agency's view that it would be challenging for a prospective 
applicant to provide adequate data to meet the statutory requirements 
for an ANDA that relies on NDA 12-122 for GLUCAGON (glucagon 
hydrochloride) for injection in the absence of comparative data with 
the animal-sourced glucagon approved in NDA 12-122.

    Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22673 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P

54294 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices DEPARTMENT OF HEALTH AND Pharmaceuticals, Inc., for the proposed Notice of this meeting is given under HUMAN SERVICES indication of major depressive disorder. the Federal Advisory Committee Act (5 FDA intends to make background U.S.C. app. 2). Food and Drug Administration material available to the public no later Dated: September 2, 2015. [Docket No. FDA–2015–N–0001] than 2 business days before the meeting. Jill Hartzler Warner, If FDA is unable to post the background Associate Commissioner for Special Medical Psychopharmacologic Drugs Advisory material on its Web site prior to the Programs. Committee; Notice of Meeting meeting, the background material will [FR Doc. 2015–22593 Filed 9–8–15; 8:45 am] be made publicly available at the AGENCY: Food and Drug Administration, location of the advisory committee BILLING CODE 4164–01–P HHS. meeting, and the background material ACTION: Notice. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND the meeting. Background material is HUMAN SERVICES This notice announces a forthcoming available at http://www.fda.gov/ meeting of a public advisory committee AdvisoryCommittees/Calendar/ Food and Drug Administration of the Food and Drug Administration default.htm. Scroll down to the (FDA). The meeting will be open to the appropriate advisory committee meeting public. [Docket No. FDA–2007–P–0248] Name of Committee: link. Psychopharmacologic Drugs Advisory Procedure: Interested persons may Determination That GLUCAGON Committee. present data, information, or views, (Glucagon Hydrochloride) for Injection, General Function of the Committee: orally or in writing, on issues pending Equivalent to 1 Milligram Base/Vial and To provide advice and before the committee. Written Equivalent to 10 Milligram Base/Vial, recommendations to the Agency on submissions may be made to the contact Was Not Withdrawn From Sale for FDA’s regulatory issues. person on or before November 23, 2015. Reasons of Safety or Effectiveness Date and Time: The meeting will be Oral presentations from the public will be scheduled between approximately 1 AGENCY: Food and Drug Administration, held on December 1, 2015, from 8 a.m. p.m. and 2 p.m. Those individuals HHS. to 5 p.m. Location: FDA White Oak Campus, interested in making formal oral ACTION: Notice. 10903 New Hampshire Ave., Bldg. 31 presentations should notify the contact person and submit a brief statement of SUMMARY: The Food and Drug Conference Center, the Great Room (rm. the general nature of the evidence or Administration (FDA) has determined 1503), Silver Spring, MD 20993–0002. arguments they wish to present, the that GLUCAGON (glucagon Answers to commonly asked questions names and addresses of proposed hydrochloride) for injection, equivalent including information regarding special participants, and an indication of the to (EQ) 1 milligram (mg) base/vial and accommodations due to a disability, approximate time requested to make EQ 10 mg base/vial, was not withdrawn visitor parking, and transportation may their presentation on or before from sale for reasons of safety or be accessed at: http://www.fda.gov/ November 13, 2015. Time allotted for effectiveness. This determination will AdvisoryCommittees/ each presentation may be limited. If the allow FDA to approve abbreviated new AboutAdvisoryCommittees/ number of registrants requesting to drug applications (ANDAs) for glucagon ucm408555.htm. speak is greater than can be reasonably hydrochloride for injection, EQ 1 mg Contact Person: Kalyani Bhatt, Center accommodated during the scheduled base/vial and EQ 10 mg base/vial, if all for Drug Evaluation and Research, Food open public hearing session, FDA may other legal and regulatory requirements and Drug Administration, 10903 New conduct a lottery to determine the are met. Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– speakers for the scheduled open public FOR FURTHER INFORMATION CONTACT: 796–9001, FAX: 301–847–8533, email: hearing session. The contact person will Daniel Orr, Center for Drug Evaluation PDAC@fda.hhs.gov, or FDA Advisory notify interested persons regarding their and Research, Food and Drug Committee Information Line, 1–800– request to speak by November 16, 2015. Administration, 10903 New Hampshire 741–8138 (301–443–0572 in the Persons attending FDA’s advisory Ave., Bldg. 51, Rm. 6206, Silver Spring, Washington, DC area). A notice in the committee meetings are advised that the MD 20993, 240–402–0979. Federal Register about last minute Agency is not responsible for providing SUPPLEMENTARY INFORMATION: In 1984, modifications that impact a previously access to electrical outlets. Congress enacted the Drug Price announced advisory committee meeting FDA welcomes the attendance of the Competition and Patent Term cannot always be published quickly public at its advisory committee Restoration Act of 1984 (Pub. L. 98–417) enough to provide timely notice. meetings and will make every effort to (the 1984 amendments), which Therefore, you should always check the accommodate persons with disabilities. authorized the approval of duplicate Agency’s Web site at http:// If you require accommodations due to a versions of drug products under an www.fda.gov/AdvisoryCommittees/ disability, please contact Kalyani Bhatt ANDA procedure. ANDA applicants default.htm and scroll down to the at least 7 days in advance of the must, with certain exceptions, show that appropriate advisory committee meeting meeting. the drug for which they are seeking link, or call the advisory committee FDA is committed to the orderly approval contains the same active information line to learn about possible conduct of its advisory committee ingredient in the same strength and Lhorne on DSK5TPTVN1PROD with NOTICES modifications before coming to the meetings. Please visit our Web site at dosage form as the ‘‘listed drug,’’ which meeting. http://www.fda.gov/ is a version of the drug that was Agenda: The committee will discuss AdvisoryCommittees/ previously approved. ANDA applicants the efficacy and safety data for new drug AboutAdvisoryCommittees/ do not have to repeat the extensive application (NDA) 21164, gepirone ucm111462.htm for procedures on clinical testing otherwise necessary to hydrochloride extended-release tablets, public conduct during advisory gain approval of a new drug application submitted by Fabre-Kramer committee meetings. (NDA). VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1

Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54295 The 1984 amendments include what that GLUCAGON (glucagon DEPARTMENT OF HEALTH AND is now section 505(j)(7) of the Federal hydrochloride) for injection, EQ 1 mg HUMAN SERVICES Food, Drug, and Cosmetic Act (21 U.S.C. base/vial and EQ 10 mg base/vial, was 355(j)(7)), which requires FDA to not withdrawn for reasons of safety or Food and Drug Administration publish a list of all approved drugs. effectiveness. The petitioner has [Docket No. FDA–2013–D–1039] FDA publishes this list as part of the identified no data or other information ‘‘Approved Drug Products With suggesting that GLUCAGON (glucagon Nonclinical Evaluation of Endocrine- Therapeutic Equivalence Evaluations,’’ hydrochloride) for injection, EQ 1 mg Related Drug Toxicity; Guidance for which is known generally as the base/vial and EQ 10 mg base/vial, was Industry; Availability ‘‘Orange Book.’’ Under FDA regulations, withdrawn for reasons of safety or AGENCY: Food and Drug Administration, drugs are removed from the list if the effectiveness. We have carefully HHS. Agency withdraws or suspends approval of the drug’s NDA or ANDA reviewed our files for records ACTION: Notice. for reasons of safety or effectiveness or concerning the withdrawal from sale of if FDA determines that the listed drug GLUCAGON (glucagon hydrochloride) SUMMARY: The Food and Drug was withdrawn from sale for reasons of for injection, EQ 1 mg base/vial and EQ Administration (FDA or Agency) is safety or effectiveness (21 CFR 314.162). 10 mg base/vial. We have also announcing the availability of a A person may petition the Agency to independently evaluated relevant guidance for industry entitled determine, or the Agency may literature and data for possible ‘‘Nonclinical Evaluation of Endocrine- determine on its own initiative, whether postmarketing adverse events. We have Related Drug Toxicity.’’ The purpose of a listed drug was withdrawn from sale reviewed the available evidence and this guidance is to clarify when for reasons of safety or effectiveness. determined that the product was not additional studies are warranted after This determination may be made at any withdrawn from sale for reasons of the standard toxicology tests have been time after the drug has been withdrawn safety or effectiveness. conducted and there is a signal for from sale, but must be made prior to potential adverse endocrine-related Accordingly, the Agency will toxicity. This guidance finalizes the approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). continue to list GLUCAGON (glucagon draft guidance entitled ‘‘Endocrine FDA may not approve an ANDA that hydrochloride) for injection, EQ 1 mg Disruption Potential of Drugs: does not refer to a listed drug. base/vial and EQ 10 mg base/vial, in the Nonclinical Evaluation’’ issued on GLUCAGON (glucagon ‘‘Discontinued Drug Product List’’ September 20, 2013. hydrochloride) for injection, EQ 1 mg section of the Orange Book. The DATES: Submit either electronic or base/vial and EQ 10 mg base/vial, is the ‘‘Discontinued Drug Product List’’ written comments on Agency guidances subject of NDA 12–122 held by Eli Lilly, delineates, among other items, drug at any time. and initially approved onNovember 14, products that have been discontinued ADDRESSES: Submit written requests for 1960. GLUCAGON is indicated for from marketing for reasons other than single copies of this guidance to the treatment of severe hypoglycemia and as safety or effectiveness. ANDAs that refer Division of Drug Information, Center for a diagnostic aid in the radiologic to GLUCAGON (glucagon Drug Evaluation and Research, Food examination of the stomach, duodenum, hydrochloride) for injection, EQ 1 mg and Drug Administration, 10001 New small bowel, and colon. base/vial and EQ 10 mg base/vial, may Under NDA 12–122, GLUCAGON Hampshire Ave., Hillandale Building, be approved by the Agency as long as 4th Floor, Silver Spring, MD 20993– (glucagon hydrochloride) for injection, they meet all other legal and regulatory EQ 1 mg base/vial and EQ 10 mg base/ 0002. Send one self-addressed adhesive requirements for the approval of label to assist that office in processing vial, was produced from animal sources. ANDAs. However, it is the Agency’s your requests. See the SUPPLEMENTARY On September 11, 1998, FDA approved Eli Lilly’s NDA 20–928 for GLUCAGON view that it would be challenging for a INFORMATION section for electronic (glucagon rDNA origin), 1mg/vial. prospective applicant to provide access to the guidance document. Subsequently, Eli Lilly discontinued adequate data to meet the statutory Submit electronic comments on the sales of animal-sourced GLUCAGON in requirements for an ANDA that relies on guidance to http://www.regulations.gov. 2002. In 2005, FDA moved animal- NDA 12–122 for GLUCAGON (glucagon Submit written comments to the sourced GLUCAGON (glucagon hydrochloride) for injection in the Division of Dockets Management (HFA– hydrochloride) for injection, EQ 1 mg absence of comparative data with the 305), Food and Drug Administration, base/vial and EQ 10 mg base/vial, to the animal-sourced glucagon approved in 5630 Fishers Lane, Rm. 1061, Rockville, ‘‘Discontinued Drug Product List’’ NDA 12–122. MD 20852. section of the Orange Book. FOR FURTHER INFORMATION CONTACT: Dated: September 2, 2015. Walter G. Jump, on behalf of Abby Jacobs, Center for Drug Evaluation Leslie Kux, and Research, Food and Drug Cornerstone Regulatory, submitted a citizen petition dated August 7, 2007 Associate Commissioner for Policy. Administration, 10903 New Hampshire (Docket No. FDA–2007–P–0248), under [FR Doc. 2015–22673 Filed 9–8–15; 8:45 am] Ave., Bldg., 22, Rm. 6474, Silver Spring, 21 CFR 10.30, requesting that the BILLING CODE 4164–01–P MD 20993–0002, 301–796–0174. Agency determine whether animal- SUPPLEMENTARY INFORMATION: sourced GLUCAGON (glucagon I. Background hydrochloride) for injection, EQ 1 mg Lhorne on DSK5TPTVN1PROD with NOTICES base/vial and EQ 10 mg base/vial, was FDA is announcing the availability of withdrawn from sale for reasons of a guidance for industry entitled safety or effectiveness. ‘‘Nonclinical Evaluation of Endocrine- After considering the citizen petition, Related Drug Toxicity.’’ This guidance reviewing Agency records, and based on focuses on nonclinical testing designed the information we have at this time, to assess the potential for a drug to FDA has determined under § 314.161 cause endocrine effects that are VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1


Document Created: 2015-12-15 09:53:22
Document Modified: 2015-12-15 09:53:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactDaniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993, 240-402-0979.
FR Citation80 FR 54294 
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