[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77723-77724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30154]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0617]
Determination That RUBRAMIN PC (Cyanocobalamin) Injection and Ten
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
the eleven drug products listed in this document were not withdrawn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 the 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 (HFD-7), 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 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength andosage form as the ``listed drug,'' which is a version
of the drug that was previously approved. Sponsors of ANDAs 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 (the 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 6-799 for RUBRAMIN PC
(cyanocobalamin)
[[Page 77724]]
Injection in the Federal Register of November 7, 2007 (72 FR 62858).)
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 6-799 RUBRAMIN PC Bristol Myers Squibb
(cyanocobalamin) Co., P.O. Box 4500,
Injection, 1 milligram Princeton, NJ 08543-
(mg)/milliliter (mL) 4500
------------------------------------------------------------------------
NDA 10-060 FLORINEF King Pharmaceuticals,
(fludrocortisone Inc., 501 Fifth St.,
acetate) Tablets, 0.1 Bristol, TN 37620
mg
------------------------------------------------------------------------
NDA 11-613 IONAMIN (phentermine UCB, Inc., 1950 Lake
resin complex) Park Dr., Smyrna, GA
Extended-Release 30080
Capsules, equivalent
to (EQ) 15 mg and 30
mg base
------------------------------------------------------------------------
NDA 17-849 BRETHINE (terbutaline AAIPharma, LLC, 2320
sulfate) Tablets, 2.5 Scientific Park Dr.,
mg and 5 mg Wilmington, NC 28405
------------------------------------------------------------------------
NDA 17-970 NOLVADEX (tamoxifen AstraZeneca
citrate) Tablets, EQ Pharmaceuticals, 1800
10 mg and 20 mg base Concord Pike, P.O.
Box 8355, Wilmington,
DE 19803-8355
------------------------------------------------------------------------
NDA 19-058 TENORMIN (atenolol) Do.
Injection, 0.5 mg/mL
------------------------------------------------------------------------
NDA 19-645 TORADOL (ketorolac Hoffman-La Roche,
tromethamine) Tablets, Inc., 340 Kingsland
10 mg St., Nutley, NJ 07110-
1199
------------------------------------------------------------------------
NDA 19-778 PRINZIDE Merck Research
(hydrochlorothiazide Laboratories, P.O.
and lisinopril) Box 1000, IG2C-50,
Tablets, 25mg/20mg North Wales, PA19454-
1009
------------------------------------------------------------------------
NDA 19-816 ORUVAIL (ketoprofen) Wyeth Pharmaceuticals,
Extended-Release P.O. Box 8299,
Capsules, 100 mg, 150 Philadelphia, PA
mg, and 200 mg 19101-8299
------------------------------------------------------------------------
NDA 19-880 PARAPLATIN Bristol Myers Squibb
(carboplatin) for Co.
Injection, 50 mg/vial,
150 mg/vial, and 450
mg/vial
------------------------------------------------------------------------
NDA 50-582 DORYX (doxycycline F.H. Faulding and Co.,
hyclate) Delayed- c/o Warner Chilcott,
Release Capsules, EQ Inc., Rockaway 80
75 mg and 100 mg base Corporate Center, 100
Enterprise Dr., suite
280, Rockaway, NJ
07866
------------------------------------------------------------------------
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: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30154 Filed 12-18-08; 8:45 am]
BILLING CODE 4160-01-S