Document ID: FDA-2012-P-1071-0003
Agency: fda
Document Type: Notice
Title: Determinations that Products were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp
Posted Date: 2013-03-04T05:00Z

[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Pages 14095-14096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04827]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-1071]

Determination That GEREF (Sermorelin Acetate) Injection, 0.5 
Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF 
(Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 
GEREF (Sermorelin Acetate)

[[Page 14096]]

injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and 
GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg 
base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) 
injection, 0.05 mg base/amp, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT:  Kathy Schreier, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 6252, Silver Spring, MD 20993-0002, 301-
796-3432.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 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). The only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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.
    GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg 
base/vial, is the subject of NDA 20-443, held by EMD Serono, and 
initially approved on September 26, 1997; and GEREF (Sermorelin 
Acetate) injection, 0.05 mg base/amp, is the subject of NDA 19-863, 
held by EMD Serono, and initially approved on December 28, 1990. GEREF 
(Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, 
is indicated for the treatment of idiopathic growth hormone deficiency 
(GHD) in children with growth failure, and GEREF (Sermorelin Acetate) 
injection, 0.05 mg base/amp, is indicated for evaluating the ability of 
the somatotroph of the pituitary gland to secrete growth hormone.
    In a letter dated December 2, 2008, EMD Serono notified FDA that 
GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/
vial, was being discontinued and requested withdrawal of NDA 20-443; 
and FDA moved that drug product to the ``Discontinued Drug Product 
List'' section of the Orange Book. In a letter dated July 11, 2008, EMD 
Serono also notified FDA that GEREF (Sermorelin Acetate) injection, 
0.05 mg base/amp, was being discontinued, and FDA moved the drug 
product to the ``Discontinued Drug Product List'' section of the Orange 
Book as well. In addition, in a letter dated December 12, 2008, EMD 
Serono requested withdrawal of NDA 19-863 for GEREF (Sermorelin 
Acetate) injection, 0.05 mg base/amp. In the Federal Register of May 
19, 2009 (74 FR 23407), FDA announced that it was withdrawing approval 
of NDA 19-863 and NDA 20-443, effective June 18, 2009.
    Alvin J. Lorman submitted a citizen petition dated October 12, 2012 
(Docket No. FDA-2012-P-1071), under 21 CFR 10.30, requesting that the 
Agency determine whether GEREF (Sermorelin Acetate) injection, 0.5 mg 
base/vial and 1.0 mg base/vial, was withdrawn from the market for 
reasons of safety and efficacy. Although the citizen petition did not 
request that we determine whether GEREF (Sermorelin Acetate) injection, 
0.05 mg base/amp, approved under NDA 19-863, was withdrawn for safety 
or efficacy, that product has also been discontinued. On our own 
initiative, we have also determined whether GEREF (Sermorelin Acetate) 
injection, 0.05 mg base/amp, was withdrawn for safety or effectiveness 
reasons.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that GEREF (Sermorelin Acetate) injection, 0.5 mg 
base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) 
injection, 0.05 mg base/amp, were not withdrawn for reasons of safety 
or effectiveness. The petitioner has identified no data or other 
information suggesting that GEREF (Sermorelin Acetate) injection, 0.5 
mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) 
injection, 0.05 mg base/amp, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of GEREF (Sermorelin Acetate) injection, 0.5 
mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) 
injection, 0.05 mg base/amp, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events for both GEREF products. We have reviewed the available 
evidence and determined that both GEREF products were not withdrawn 
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GEREF (Sermorelin 
Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF 
(Sermorelin Acetate) injection, 0.05 mg base/amp, 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 GEREF (Sermorelin Acetate) 
injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin 
Acetate) injection, 0.05 mg base/amp, 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: February 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04827 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P