[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Pages 5560-5561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0175]


Determination That LYMPHAZURIN (Isosulfan Blue) Injectable and 
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety 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 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withdrawn from sale for reasons of safety or effectiveness.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: Amy Hopkins, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418, [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

[[Page 5561]]

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. (As requested by the 
applicants, FDA withdrew approval of NDA 018310 for LYMPHAZURIN 
(isosulfan blue) Injectable in the Federal Register of December 5, 2014 
(79 FR 72186) and NDA 020151 for EFFEXOR (venlafaxine HCl) Tablets in 
the Federal Register of July 19, 2013 (78 FR 43210).)

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 018310..................  LYMPHAZURIN           Covidien, 60
                               (isosulfan blue)      Middletown Ave.,
                               Injectable;           North Haven, CT
                               Injection, 1%.        06473.
NDA 019966..................  TEMOVATE (clobetasol  Fougera
                               propionate)           Pharmaceuticals
                               Solution; Topical,    Inc., 1 Health
                               0.05%.                Plaza, Bldg. 434,
                                                     East Hanover, NJ
                                                     07936.
NDA 020151..................  EFFEXOR (venlafaxine  Wyeth
                               hydrochloride         Pharmaceuticals
                               (HCl)) Tablet;        Inc., 235 East 42nd
                               Oral, Equivalent to   St., New York, NY
                               (EQ) 12.5 milligram   10017.
                               (mg) Base; EQ 25 mg
                               Base; EQ 37.5 mg
                               Base; EQ 50 mg
                               Base; EQ 75 mg
                               Base; EQ 100 mg
                               Base.
NDA 020214..................  ZEMURON (rocuronium   Organon USA Inc.,
                               bromide)              351 North
                               Injectable;           Sunmeytown Pike,
                               Injection 100 mg/10   North Wales, PA
                               milliliter (mL); 50   19454.
                               mg/5 mL; 10 mg/mL.
NDA 021040..................  PREFEST (estradiol;   Teva Branded
                               norgestimate)         Pharmaceutical
                               Tablet; Oral, 1 mg,   Products R&D, Inc.,
                               1 mg/0.09 mg.         41 Moores Rd., P.O.
                                                     Box 4011, Frazer,
                                                     PA 19355.
NDA 021621..................  CHILDREN'S ZYRTEC     McNeil Consumer
                               ALLERGY (cetirizine   Healthcare, 7050
                               HCl) and CHILDREN'S   Camp Hill Rd., Fort
                               ZYRTEC HIVES RELIEF   Washington, PA
                               (cetirizine HCl)      19034.
                               Chewable Tablet;
                               Oral, 5 mg; 10 mg.
NDA 050783..................  PERIOSTAT             Galderma
                               (doxycycline          Laboratories, L.P.,
                               hyclate) Tablet;      14501 North
                               Oral, EQ 20 mg Base.  Freeway, Fort
                                                     Worth, TX 76177.
------------------------------------------------------------------------

    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: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01859 Filed 1-30-15; 8:45 am]
BILLING CODE 4164-01-P