[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Page 45267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19110]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0318]
Determination That INVERSINE (Mecamylamine Hydrochloride) Tablet
and Six Other Drug Products Were Not Withdrawn From Sale for Reasons of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 the
seven drug products listed in this document were not withdrawn from
sale for reasons of safety or effectiveness. This determination means
that FDA will not begin procedures to withdraw approval of abbreviated
new drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.
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 approved 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 generally known as the ``Orange
Book.'' Under FDA regulations, a drug is withdrawn 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved; (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved; and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for reasons
of safety or effectiveness, the Agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed. (As requested by the
applicant, FDA withdrew approval of NDA 021039 for AGENERASE
(amprenavir) Oral Solution in the Federal Register of July 21, 2010 (75
FR 42455).)
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Application No. Drug Applicant
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NDA 010251.................. INVERSINE Targacept, Inc., 200
(mecamylamine East 1st St., Suite
hydrochloride 300, Winston Salem,
(HCl)) Tablet, 2.5 NC 27101-4165
milligrams (mg).
NDA 011552.................. STELAZINE GlaxoSmithKline, 5
(trifluoperazine Moore Dr., P.O. Box
HCl) Injection, 13398, Research
Equivalent to (EQ) Triangle Park, NC
2 mg base/ 27709-3398
milliliter (mL).
NDA 011552.................. STELAZINE Do.
(trifluoperazine
HCl) Oral
Concentrate, EQ 10
mg base/mL.
NDA 016798.................. SINEQUAN (doxepin Pfizer Laboratories,
HCl) Capsules, EQ Division of Pfizer
10 mg base, EQ 25 Inc., 235 East 42nd
mg base, EQ 50 mg St., New York, NY
base, EQ 75 mg 10017
base, EQ 100 mg
base, and EQ 150 mg
base.
NDA 017516.................. SINEQUAN (doxepin Do.
HCl) Oral
Concentrate, EQ 10
mg base/mL.
NDA 019201.................. VOLTAREN (diclofenac Novartis
sodium) Delayed- Pharmaceuticals
Release Tablet, 75 Corp., One Health
mg. Plaza, East
Hanover, NJ 07936-
1080
NDA 021039.................. AGENERASE GlaxoSmithKline
(amprenavir) Oral
Solution, 15 mg/mL.
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FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19110 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P