[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Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety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withdrawn from sale for reasons of safety or effectiveness.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).)
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Application No. Drug Applicant
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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.
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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 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]
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