Document ID: FDA-2010-N-0391-0001
Agency: fda
Document Type: Notice
Title: Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness; Determinations: MOTRIN (Ibuprofen) Tablets and Four Other Drug Products
Posted Date: 2010-08-10T04:00Z

[Federal Register: August 10, 2010 (Volume 75, Number 153)]
[Notices]               
[Page 48352-48353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au10-59]                         

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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Products Were Not Withdrawn From Sale for Reasons of Safety or 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.

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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five drug products listed in this document were not withdrawn from sale 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).)

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                Application No.                                         Drug                                              Applicant
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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
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NDA 18-303                                           LOPRESSOR HCT (hydrochlorothiazide; metoprolol     Novartis Pharmaceuticals Corp., 59 Rte. 10, East
                                                                  tartrate ) Tablets, 50 mg; 100 mg                               Hanover, NJ 07936-1080
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[[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
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NDA 18-423                                      HIBICLENS (chlorhexidine gluconate) Topical Sponge,   Molnycke Health Care, 5550 Peachtree Parkway, Ste.
                                                                                                4 %                              500, Norcross, GA 30092
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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