[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48352-48353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19638]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0391]
Determination That MOTRIN (Ibuprofen) Tablets and Four 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Products Were Not Withdrawn From Sale for Reasons of Safety or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) has determined that the
five drug products listed in this document were not withdrawn from sale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: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 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 only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the 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 withdrawn 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 reasons
of safety or effectiveness, 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
applicant, FDA withdrew approval of NDA 18-354 for ORTHO-NOVUM 10/11-21
and 10/11-28 (ethinyl estradiol; norethindrone) Tablets in the Federal
Register of February 11, 2009 (74 FR 6896).)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application No. Drug Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 17-463 MOTRIN (ibuprofen) Tablets, 300 milligrams (mg), McNeil Consumer Healthcare, 7050 Camp Hill Rd.,
400 mg, 600 mg, and 800 mg Fort Washington, PA 19034
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 18-303 LOPRESSOR HCT (hydrochlorothiazide; metoprolol Novartis Pharmaceuticals Corp., 59 Rte. 10, East
tartrate ) Tablets, 50 mg; 100 mg Hanover, NJ 07936-1080
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 48353]]
NDA 18-354 ORTHO-NOVUM 10/11-21 and 10/11-28 (ethinyl Ortho McNeil Janssen Pharmaceuticals, Inc., 1125
estradiol; norethindrone) Tablets, 0.035 mg, 0.035 Trenton Harbourton Rd., Titusville, NJ 08560
mg; 0.5 mg, 1 mg
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 18-423 HIBICLENS (chlorhexidine gluconate) Topical Sponge, Molnycke Health Care, 5550 Peachtree Parkway, Ste.
4 % 500, Norcross, GA 30092
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 19-436 PRIMACOR (milrinone lactate) Injection, Equivalent Sanofi Aventis U.S. LLC, 55 Corporate Dr.,
to (EQ) 1 mg base/milliliter Bridgewater, NJ 08807
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19638 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S