Notices - 76 fr 51037 - determination that halflytely and bisacodyl tablets bowel prep kit (containing two bisacodyl delayed release tablets 5 milligrams) was withdrawn from sale for reasons of safety or effectiveness

Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices
The OMB-approved ABCs MRSA form take about 5 minutes and the telephone patients to be contacted for a telephone Daniel Holcomb,
Reports Clearance Officer, Centers for Disease [FR Doc. 2011–20919 Filed 8–16–11; 8:45 am] SUPPLEMENTARY INFORMATION: In 1984,
BILLING CODE 4163–18–P
Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) ANDA that does not refer to a listed DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
2010–P–0507), submitted under § 10.30 [Docket No. FDA–2010–P–0507]
(Perrigo). The petition requests that the Determination That Halflytely and
Bisacodyl Tablets Bowel Prep Kit
(Containing Two Bisacodyl Delayed
Release Tablets, 5 Milligrams) Was
the ‘‘listed drug,’’ which is a version of Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY: Food and Drug Administration,
the extensive clinical testing otherwise Braintree Laboratories, Inc. (Braintree), ACTION: Notice.
SUMMARY: The Food and Drug
Food, Drug, and Cosmetic Act (21 U.S.C. indicated for the cleansing of the colon release tablets, 5 milligrams (mg) (10-mg publish a list of all approved drugs. bisacodyl)) was withdrawn from sale for FDA publishes this list as part of the Therapeutic Equivalence Evaluations,’’ Prep Kit (10-mg bisacodyl) as of July 17, ‘‘Orange Book.’’ Under FDA regulations, to the ‘‘Discontinued Drug Product List’’ for reasons of safety or effectiveness, or FOR FURTHER INFORMATION CONTACT:
safety or effectiveness (21 CFR 314.162). literature, data from clinical trials, and Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices
DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HUMAN SERVICES
under § 314.161, that Halflytely and Bisacodyl Tablets Bowel Prep Kit (10- Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2010–D–0246]
[Docket No. FDA–2007–D–0068; formerly
Docket No. 2007D–0290]
Guidance for Industry on Residual
containing a total dose of 10 milligrams Drug in Transdermal and Related Drug
Draft Guidance for Industry: Cell
Delivery Systems; Availability
Selection Devices for Point of Care
approval from FDA on July 16, 2010, for Production of Minimally Manipulated
AGENCY: Food and Drug Administration,
Autologous Peripheral Blood Stem
Bisacodyl Tablets Bowel Prep Kit (PEG– Cells; Withdrawal of Draft Guidance
ACTION: Notice.
3350, sodium chloride, sodium bicarbonate, and potassium chloride for SUMMARY: The Food and Drug
AGENCY: Food and Drug Administration,
The data available from a clinical study ACTION: Notice; withdrawal.
entitled ‘‘Residual Drug in Transdermal and Related Drug Delivery Systems.’’ SUMMARY: The Food and Drug
This guidance provides recommendations to developers and Administration (FDA) is announcing the manufacturers of transdermal drug Autologous Peripheral Blood Stem Cells (PBSCs)’’ dated July 2007. because there is less abdominal fullness DATES: August 17, 2011.
with the 5-mg product. Furthermore, the FOR FURTHER INFORMATION CONTACT:
of residual drug substance at the end of approved labeling for the 10-mg product Rockville Pike, suite 200N, Rockville, SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
DATES: Submit either electronic or
additional clinical studies of safety and guidance entitled ‘‘Draft Guidance for ADDRESSES: Submit written requests for
Division of Drug Information, Center for Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send potassium chloride for oral solution and issued in 2007, has gained additional two bisacodyl delayed release tablets, 5 requests. See the SUPPLEMENTARY
INFORMATION section for electronic
published in the Orange Book. FDA will them. Based on these comments and Leslie Kux,
Division of Dockets Management (HFA– 305), Food and Drug Administration, Acting Assistant Commissioner for Policy. [FR Doc. 2011–20853 Filed 8–16–11; 8:45 am] Selection Devices for Point of Care Production of Minimally Manipulated BILLING CODE 4160–01–P
Autologous Peripheral Blood Stem Cells FOR FURTHER INFORMATION CONTACT:
(PBSCs).’’
Terrance Ocheltree, Center for Drug Evaluation and Research, Food and Leslie Kux,
Acting Assistant Commissioner for Policy. [FR Doc. 2011–20862 Filed 8–16–11; 8:45 am] BILLING CODE 4160–01–P
SUPPLEMENTARY INFORMATION:

Source: http://setonresourcecenter.net/register/2011/aug/17/2011-20853.pdf