[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Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for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drug products listed in this document were not withdrawn from sale for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.
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Application No. Drug Applicant
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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.
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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 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