[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Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety 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10 drug products listed in this document were not withdrawn from sale 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
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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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