[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Pages 66911-66912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27740]
[[Page 66911]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3894]
Determination That TENSILON and TENSILON Preservative Free
(Edrophonium Chloride) Injectable and Other Drug Products Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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withdrawn from sale for reasons of safety or effectiveness.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: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363,
[email protected].
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 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 007959................ TENSILON and TENSILON IGI Laboratories,
Preservative Free Inc., 105 Lincoln
(edrophonium Ave., Buena, NJ
chloride) 08310.
Injectable;
Intravenous, 10
milligrams/
milliliter (mg/mL).
NDA 013416................ NORGESIC and NORGESIC Medicis
FORTE (aspirin, Pharmaceuticals,
caffeine, Division of Valeant
orphenadrine Pharmaceuticals
citrate) Tablet; North America, LLC,
Oral,385 mg/30 mg/25 400 Somerset
mg; 770 mg/60 mg/50 Corporate Blvd.,
mg. Bridgewater, NJ
08807.
NDA 018225................ BUMEX (bumetanide) Validus
Tablet; Oral, 0.5 Pharmaceuticals,
mg; 1 mg; 2 mg. LLC, 119 Cherry Hill
Rd., Suite 310,
Parsippany, NJ
07054.
NDA 018343................ CAPOTEN (captopril) Par Pharmaceutical
Tablet; Oral, 12.5 Inc., 1 Ram Ridge
mg; 25 mg; 50 mg; Rd., Chestnut Ridge,
100 mg. NY 10977.
NDA 019322................ TEMOVATE (clobetasol Fougera
propionate) Cream; Pharmaceuticals
Topical, 0.05%. Inc., 60 Baylis Rd.,
P.O. Box 2006,
Melville, NY 11747.
NDA 020337................ TEMOVATE (clobetasol Do.
propionate) Gel;
Topical, 0.05%.
NDA 020340................ TEMOVATE E Do.
(clobetasol
propionate) Cream;
Topical, 0.05%.
NDA 020638................ VISTIDE (cidofovir) Gilead Sciences,
Injectable; Inc., 333 Lakeside
Intravenous, 75 mg Dr., Foster City, CA
base/mL. 94404.
NDA 021700................ AVANDARYL SmithKline Beecham
(glimepiride, (Cork) Ltd.,
rosiglitazone Ireland, 2301
maleate) Tablet; Renaissance Blvd.,
Oral, 1 mg/4 mg; 2 Mail Code RN 0420,
mg/4 mg; 4 mg/4 mg; King of Prussia, PA
2 mg/8 mg; 4 mg/8 mg. 19406.
NDA 022411................ OLEPTRO (trazodone Angelini Pharma Inc.,
HCl); Extended- 8322 Helgerman Ct.,
Release Tablet; Gaithersburg, MD
Oral, 150 mg; 300 mg. 20877.
NDA 050461................ ANCEF (cefazolin GlaxoSmithKline, 1
sodium) Injectable; Franklin Plaza, P.O.
Intravenous, 1 gram Box 7929,
(g)/vial; 10 g/vial. Philadelphia, PA
19101.
NDA 050495................ AMIKIN (amikacin Apothecon, Inc., P.O.
sulfate) Injectable; Box 4500, Princeton,
Intravenous, EQ 50 NJ 08543.
mg base/mL; 250 mg
base/mL.
ANDA 064169............... Cefazolin Sodium Fresenius Kabi USA,
Injectable; LLC, 3 Corporate
Intravenous, 500 mg Dr., Lake Zurich, IL
base/vial; 1 g base/ 60047.
vial.
------------------------------------------------------------------------
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
[[Page 66912]]
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.
Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27740 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P