Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications, 50702-50703 [2012-20588]
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ACTION:
Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Notices
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Agenda: On October 24, 2012, the
committee will discuss, make
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premarket approval application
supplement to expand the indications
for use of the Selenia Dimensions 3D
System with C-View Software Module,
sponsored by Hologic, Inc.
The Selenia Dimensions 3D System is
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The new C-View Software Module
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–20608 Filed 8–21–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Cardiovascular and Renal Drugs
Advisory Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the
Cardiovascular and Renal Drugs
Advisory Committee scheduled for
September 14, 2012, is cancelled. The
meeting is no longer needed. This
meeting was announced in the Federal
Register of July 23, 2012 (77 FR 43093).
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
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advisory committee information or visit
our Web site at https://www.fda.gov/
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SUMMARY:
Dated: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–20607 Filed 8–21–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0839]
Ranbaxy Laboratories Limited;
Withdrawal of Approval of 27
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\22AUN1.SGM
Notice.
22AUN1
Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Notices
The Food and Drug
Administration (FDA) is withdrawing
approval of 27 abbreviated new drug
applications (ANDAs) held by Ranbaxy
Laboratories Ltd., c/o Ranbaxy Inc.
(Ranbaxy), 600 College Rd. East,
Princeton, NJ 08540. The drug products
are no longer marketed, and Ranbaxy
has requested that the approval of the
applications be withdrawn.
DATES: Effective date: September 21,
2012.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The drug
products listed in table 1 in this
document are no longer marketed, and
Ranbaxy has requested that FDA
withdraw approval of the applications.
50703
The company has also waived its
opportunity for a hearing. Ranbaxy
requested withdrawal of approval under
a Consent Decree of Permanent
Injunction (Decree) entered in United
States v. Ranbaxy Laboratories, Ltd. et
al., JFM 12–250 (D. Md.) on January 26,
2012. The Decree specifies that Ranbaxy
must never submit another application
to FDA for these withdrawn drug
products and must never transfer these
ANDAs to a third party.
TABLE 1
Application No.
064155
064156
064164
064165
064166
065015
065018
065043
065080
065092
065100
065159
065198
065202
075226
076021
076220
076386
076413
076445
076457
076580
076875
076951
077211
077327
078849
Drug
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Cefaclor for Oral Suspension USP, 375 milligrams (mg)/5 milliliters (mL).
Cefaclor Capsules USP, 250 mg and 500 mg.
Cefaclor for Oral Suspension USP, 250 mg/5 mL.
Cefaclor for Oral Suspension USP, 187 mg/5 mL.
Cefaclor for Oral Suspension USP, 125 mg/5 mL.
Cefadroxil Capsules USP, 500 mg.
Cefadroxil Tablets USP, 1 gram.
Cefuroxime Axetil Tablets USP, 125 mg, 250 mg, and 500 mg.
Dispermox (amoxicillin tablets for oral suspension USP), 200 mg and 400 mg.
Raniclor (cefaclor chewable tablets USP), 125 mg, 187 mg, 250 mg, and 375 mg.
Panixine Disperdose (cephalexin tablets for oral suspension USP), 125 mg and 250 mg.
Dispermox (amoxicillin tablets for oral suspension USP), 600 mg.
Cefprozil Tablets USP, 250 mg and 500 mg.
Cefprozil for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL.
Etodolac Tablets USP, 400 mg and 500 mg.
Terazosin Hydrochloride (HCl) Capsules, 1 mg, 2 mg, 5 mg, and 10 mg.
Ofloxacin Tablets, 200 mg, 300 mg, and 400 mg.
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg.
Metformin HCl Extended-Release Tablets USP, 500 mg.
Pravastatin Sodium Tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg.
Ganciclovir Capsules, 250 mg and 500 mg.
Fosinopril Sodium Tablets USP, 10 mg, 20 mg, and 40 mg.
Glimepiride Tablets USP, 1 mg, 2 mg, 4 mg, and 8 mg.
Nitrofurantoin/Nitrofurantoin Macrocrystalline Capsules, 75 mg/25 mg.
Metformin HCl Extended-Release Tablets USP, 750 mg.
Zidovudine Tablets USP, 300 mg.
Ramipril Capsules, 5 mg and 10 mg.
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Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective
September 21, 2012. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
FD&C Act (21 U.S.C. 331(a) and (d)).
Dated: August 15, 2012.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. 2012–20588 Filed 8–21–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Dermatology
and Rheumatology.
Date: September 19, 2012.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Aruna K Behera, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4211,
MSC 7814, Bethesda, MD 20892, 301–435–
6809, beheraak@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Nanotechnology Study Section.
Date: September 20–21, 2012.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel, 1127
Connecticut Avenue NW., Washington, DC
20036.
Contact Person: James J Li, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Notices]
[Pages 50702-50703]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0839]
Ranbaxy Laboratories Limited; Withdrawal of Approval of 27
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 50703]]
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 27 abbreviated new drug applications (ANDAs) held by Ranbaxy
Laboratories Ltd., c/o Ranbaxy Inc. (Ranbaxy), 600 College Rd. East,
Princeton, NJ 08540. The drug products are no longer marketed, and
Ranbaxy has requested that the approval of the applications be
withdrawn.
DATES: Effective date: September 21, 2012.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The drug products listed in table 1 in this
document are no longer marketed, and Ranbaxy has requested that FDA
withdraw approval of the applications. The company has also waived its
opportunity for a hearing. Ranbaxy requested withdrawal of approval
under a Consent Decree of Permanent Injunction (Decree) entered in
United States v. Ranbaxy Laboratories, Ltd. et al., JFM 12-250 (D. Md.)
on January 26, 2012. The Decree specifies that Ranbaxy must never
submit another application to FDA for these withdrawn drug products and
must never transfer these ANDAs to a third party.
Table 1
------------------------------------------------------------------------
Application No. Drug
------------------------------------------------------------------------
064155............................ Cefaclor for Oral Suspension USP,
375 milligrams (mg)/5 milliliters
(mL).
064156............................ Cefaclor Capsules USP, 250 mg and
500 mg.
064164............................ Cefaclor for Oral Suspension USP,
250 mg/5 mL.
064165............................ Cefaclor for Oral Suspension USP,
187 mg/5 mL.
064166............................ Cefaclor for Oral Suspension USP,
125 mg/5 mL.
065015............................ Cefadroxil Capsules USP, 500 mg.
065018............................ Cefadroxil Tablets USP, 1 gram.
065043............................ Cefuroxime Axetil Tablets USP, 125
mg, 250 mg, and 500 mg.
065080............................ Dispermox (amoxicillin tablets for
oral suspension USP), 200 mg and
400 mg.
065092............................ Raniclor (cefaclor chewable tablets
USP), 125 mg, 187 mg, 250 mg, and
375 mg.
065100............................ Panixine Disperdose (cephalexin
tablets for oral suspension USP),
125 mg and 250 mg.
065159............................ Dispermox (amoxicillin tablets for
oral suspension USP), 600 mg.
065198............................ Cefprozil Tablets USP, 250 mg and
500 mg.
065202............................ Cefprozil for Oral Suspension USP,
125 mg/5 mL and 250 mg/5 mL.
075226............................ Etodolac Tablets USP, 400 mg and 500
mg.
076021............................ Terazosin Hydrochloride (HCl)
Capsules, 1 mg, 2 mg, 5 mg, and 10
mg.
076220............................ Ofloxacin Tablets, 200 mg, 300 mg,
and 400 mg.
076386............................ Fluconazole Tablets, 50 mg, 100 mg,
150 mg, and 200 mg.
076413............................ Metformin HCl Extended-Release
Tablets USP, 500 mg.
076445............................ Pravastatin Sodium Tablets USP, 10
mg, 20 mg, 40 mg, and 80 mg.
076457............................ Ganciclovir Capsules, 250 mg and 500
mg.
076580............................ Fosinopril Sodium Tablets USP, 10
mg, 20 mg, and 40 mg.
076875............................ Glimepiride Tablets USP, 1 mg, 2 mg,
4 mg, and 8 mg.
076951............................ Nitrofurantoin/Nitrofurantoin
Macrocrystalline Capsules, 75 mg/25
mg.
077211............................ Metformin HCl Extended-Release
Tablets USP, 750 mg.
077327............................ Zidovudine Tablets USP, 300 mg.
078849............................ Ramipril Capsules, 5 mg and 10 mg.
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective September 21, 2012. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)).
Dated: August 15, 2012.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-20588 Filed 8-21-12; 8:45 am]
BILLING CODE 4160-01-P
