[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Pages 14095-14096]
From the Federal Register Online via the Government Publishing 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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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