[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67365-67367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26856]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1361]


Determination That Adderall (Amphetamine Aspartate; Amphetamine 
Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) 
Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for 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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[[Page 67366]]

SUMMARY: The Food and Drug Administration (FDA) has determined that the 
drug products listed in this document were not withdrawn from sale for 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: Amy Hopkins, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-
796-5418.

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 
sponsors 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. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA).
    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 safety or 
effectiveness reasons, 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 011522..................  ADDERALL              Teva Womens Health
                               (amphetamine          Inc., 41 Moores
                               aspartate;            Rd., P.O. Box 4011,
                               amphetamine           Frazer, PA 19355.
                               sulfate;
                               dextroamphetamine
                               saccharate;
                               dextroamphetamine
                               sulfate) Tablet;
                               Oral, 5 milligrams
                               (mg), 7.5 mg, 10
                               mg, 12.5 mg, 15 mg,
                               20 mg, 30 mg.
NDA 011601..................  KENALOG               Apothecon
                               (triamcinolone        Pharmaceuticals,
                               acetonide) Cream;     General Offices,
                               Topical, 0.025%,      P.O. Box 4500,
                               0.1%.                 Princeton, NJ 08543-
                                                     4500.
NDA 013601..................  MUCOMYST              Do.
                               (acetylcysteine)
                               Solution;
                               Inhalation, Oral,
                               10%, 20%.
NDA 018531..................  NITROGLYCERIN         Hospira Inc., 275
                               (nitroglycerin)       North Field Dr.,
                               Injectable;           Bldg. H2, Lake
                               Injection, 5mg/       Forest, IL 60045-
                               milliliter (mL).      5046.
NDA 018726..................  WESTCORT              Ranbaxy Inc., 600
                               (hydrocortisone       College Rd., East
                               valerate) Ointment;   Princeton, NJ
                               Topical, 0.2%.        08540.
NDA 018830..................  TAMBOCOR (flecainide  Medicis
                               acetate) Tablet;      Pharmaceutical
                               Oral, 50 mg, 100      Corp., 7720 North
                               mg, 150 mg.           Dobson Rd.,
                                                     Scottsdale, AZ
                                                     85256.
NDA 020336..................  DYNACIRC CR           GlaxoSmithKline
                               (isradipine)          LLC., 2711
                               Tablet; Extended      Centerville Rd.,
                               Release, Oral, 5      Ste. 400,
                               mg, 10 mg.            Wilmington, DE
                                                     19808.
NDA 020518..................  RETROVIR              ViiV Healthcare, 5
                               (zidovudine)          Moore Dr., Research
                               Tablet; Oral, 300     Triangle Park, NC
                               mg.                   27709.
NDA 021745..................  RYZOLT (tramadol      Purdue Pharma
                               HCl) Tablet;          Products LP, 1
                               Extended Release,     Stamford Forum,
                               Oral, 100 mg, 200     Stamford, CT 06901.
                               mg, 300 mg.
NDA 022021..................  ALTACE (ramipril)     Pfizer Inc., 501 5th
                               Tablet; Oral, 1.25    St., Bristol, TN
                               mg, 2.5 mg, 5 mg,     37620.
                               10 mg.
NDA 050808..................  SOLODYN (minocycline  Medicis
                               HCl) Tablet;          Pharmaceutical
                               Extended Release;     Corp., 7720 North
                               Equivalent to (EQ)    Dobson Rd.,
                               45 mg Base, EQ 90     Scottsdale, AZ
                               mg Base, EQ 135 mg    85256.
                               Base.
ANDA 081295.................  ESTRACE (estradiol)   Bristol Myers
                               Tablet; Oral, 0.5     Squibb, P.O. Box
                               mg.                   4000, Princeton, NJ
                                                     08543.
ANDA 084499.................  ESTRACE (estradiol)   Do.
                               Tablet; Oral, 1 mg.
ANDA 084500.................  ESTRACE (estradiol)   Do.
                               Tablet; Oral, 2 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 and ANDAs listed in this 
document are unaffected by the discontinued marketing of the products 
subject to those NDAs and ANDAs. 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.


[[Page 67367]]


    Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26856 Filed 11-8-13; 8:45 am]
BILLING CODE 4160-01-P