[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11488-11489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4594]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0318]
Determination That MEGACE (Megestrol Acetate) Tablets and Nine
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety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
10 drug products listed in this document were not withdrawn from sale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 (the FD&C 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
applicants, FDA withdrew approval of NDA 18-101 for SYMMETREL
(amantadine hydrochloride (HCl)) Tablets and ANDA 84-935 for DEXEDRINE
(dextroamphetamine sulfate) Tablets in the Federal Register of July 21,
2010 (75 FR 42455).)
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Application No. Drug Applicant
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NDA 16-979.................... MEGACE (megestrol Bristol Myers
acetate) Tablets, Squibb, P.O. Box
20 milligrams (mg) 4000, Princeton,
and 40 mg. NJ 08543-4000.
NDA 17-911.................... CLINORIL (sulindac) Merck Research
Tablet, 150 mg. Laboratories,
Sumneytown Pike,
West Point, PA
19486.
NDA 18-101.................... SYMMETREL Endo
(amantadine HCl) Pharmaceuticals,
Tablet, 100 mg. Inc., 100 Endo
Blvd., Chadds
Ford, PA 19317.
NDA 18-482.................... PROCARDIA Pfizer Inc., 235
(nifedipine) East 42nd St., New
Capsule, 20 mg. York, NY 10017-
5755.
NDA 18-768.................... VEPESID (etoposide) Bristol Myers
Injection, 20 mg/ Squibb.
milliliter (mL).
NDA 20-262.................... TAXOL (paclitaxel) Do.
Injection, 6 mg/mL.
NDA 20-450.................... CEREBYX Parke Davis, 2800
(fosphenytoin Plymouth Rd., Ann
sodium) Injection, Arbor, MI 48106-
Equivalent to (EQ) 1047.
50 mg phenytoin
sodium/mL.
NDA 50-527.................... DURICEF (cefadroxil/ Warner Chilcott,
cefadroxil Inc., 100
hemihydrate) Oral Enterprise Dr.,
Suspension, EQ 250 Suite 280,
mg base/5mL and EQ Rockaway, NJ
500 mg base/5 mL. 07866.
ANDA 84-051................... DEXTROSTAT Shire Development,
(dextroamphetamine Inc., 725
sulfate) Tablets, Chesterbrook
5 mg and 10 mg. Blvd., Wayne, PA
19087.
[[Page 11489]]
ANDA 84-935................... DEXEDRINE GlaxoSmithKline, 5
(dextroamphetamine Moore Dr., P.O.
sulfate) Tablet, 5 Box 13398,
mg. Research Triangle
Park, NC 27709-
3398.
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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 the labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: February 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4594 Filed 3-1-11; 8:45 am]
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