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Hydrochloride) for Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10 Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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

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(glucagon hydrochloride) for injection, equivalent to (EQ) 1 milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from sale for reasons of safety or effectiveness.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, 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Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety 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milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from 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