[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Notices]
[Pages 75886-75887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0826]


Determination That DEMULEN 1/50-28 (Ethinyl Estradiol; Ethynodiol 
Diacetate) Tablet and Four Other Drug Products Were Not Withdrawn From 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 
five drug products listed in this document were not withdrawn from sale 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 (Public Law 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 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).
    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.

------------------------------------------------------------------------
        Application No.                  Drug               Applicant
------------------------------------------------------------------------
NDA 016936....................  DEMULEN 1/50-28         GD Searle, LLC,
                                 (ethinyl estradiol;     4901 Searle
                                 ethynodiol diacetate)   Pkwy., Skokie,
                                 Tablet, 0.05 mg; 1 mg.  IL 60077.
NDA 018160....................  DEMULEN 1/35-28         Do.
                                 (ethinyl estradiol;
                                 ethynodiol diacetate)
                                 Tablet, 0.035 mg; 1
                                 mg.

[[Page 75887]]

 
NDA 018168....................  DEMULEN 1/35-21         Do.
                                 (ethinyl estradiol;
                                 ethynodiol diacetate)
                                 Tablet, 0.035 mg; 1
                                 mg.
NDA 019190....................  TRIPHASIL-28 (ethinyl   Wyeth
                                 estradiol;              Pharmaceuticals
                                 levonorgestrel)         , Inc., P.O.
                                 Tablet, 0.03 mg, 0.04   Box 8299,
                                 mg, 0.03 mg; 0.05 mg,   Philadelphia,
                                 0.075 mg, 0.125 mg.     PA 19101-8299.
NDA 019192....................  TRIPHASIL-21 (ethinyl   Do.
                                 estradiol;
                                 levonorgestrel)
                                 Tablet, 0.03 mg, 0.04
                                 mg, 0.03 mg; 0.05 mg,
                                 0.075 mg, 0.125 mg.
------------------------------------------------------------------------

    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: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31146 Filed 12-2-11; 8:45 am]
BILLING CODE 4164-01-P