[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Pages 66911-66912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27740]

[[Page 66911]]



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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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, 

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listed drug was withdrawn from sale for reasons of safety or 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.
                             Intravenous, 10
                             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
NDA 018225................  BUMEX (bumetanide)     Validus
                             Tablet; Oral, 0.5      Pharmaceuticals,
                             mg; 1 mg; 2 mg.        LLC, 119 Cherry Hill
                                                    Rd., Suite 310,
                                                    Parsippany, NJ
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.
                             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
NDA 050495................  AMIKIN (amikacin       Apothecon, Inc., P.O.
                             sulfate) Injectable;   Box 4500, Princeton,
                             Intravenous, EQ 50     NJ 08543.
                             mg base/mL; 250 mg
ANDA 064169...............  Cefazolin Sodium       Fresenius Kabi USA,
                             Injectable;            LLC, 3 Corporate
                             Intravenous, 500 mg    Dr., Lake Zurich, IL
                             base/vial; 1 g base/   60047.

    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]