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Halflytely and Bisacodyl Tablets Bowel Prep Kit (Containing Two Bisacodyl Delayed Release Tablets, 5 Milligrams) Was Withdrawn From Sale for Reasons of Safety or Effectiveness, 51037-51038 [2011-20853]

Download as PDF 51037 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices An estimated total of 450 new patients (150 patients with HACO MRSA infection and 300 patients without HACO MRSA infection) will be contacted for the MRSA interview annually. This estimate is based on the numbers of MRSA cases reported by the EIP sites annually (https://www.cdc.gov/ abcs/reports-findings/survreports/ mrsa08.html) who are 18 years of age or older, had onset of the MRSA infection in the community or within 3 days of hospital admission, and history of hospitalization in the prior 3 months. There are no costs to respondents other than their time. The total response burden for the study is estimated as follows: The OMB-approved ABCs MRSA form (#0920–0802) will be used to identify patients to be contacted for a telephone interview. These 450 patients will be screened for eligibility and those considered to be eligible will complete the telephone interview. We anticipate that 350 of the 450 patients screened will complete the telephone interview across all 7 EIP sites per year. We anticipate the screening questions to take about 5 minutes and the telephone interview 20 minutes per respondent. TABLE—ESTIMATED BURDEN Number of responses per respondent Number of respondents Average burden per respondent (in hours) Type of respondents Form name Hospital Patients ............................... Screening Form ................................ Telephone interview ......................... 450 350 1 1 5/60 20/60 38 117 Total ........................................... ........................................................... ........................ ........................ ........................ 155 Dated: August 10, 2011. Daniel Holcomb, Reports Clearance Officer, Centers for Disease Control and Prevention. Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993–0002, 301– 796–3601. [FR Doc. 2011–20919 Filed 8–16–11; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–P–0507] 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that Halflytely and Bisacodyl Tablets Bowel Prep Kit (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bowel prep kits containing PEG–3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg. FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug Evaluation and Research, Food and Emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:22 Aug 16, 2011 Jkt 223001 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 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 (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, drugs are 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). PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Total burden (in hours) Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. On September 23, 2010, FDA received a citizen petition (Docket No. FDA– 2010–P–0507), submitted under § 10.30 (21 CFR 10.30), from Perrigo Company (Perrigo). The petition requests that the Agency determine whether Halflytely and Bisacodyl Tablets Bowel Prep Kit (PEG–3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg) (Halflytely and Bisacodyl Tablets Bowel Prep Kit (10mg bisacodyl)), manufactured by Braintree Laboratories, Inc. (Braintree), was withdrawn from sale for reasons of safety or effectiveness. Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) (NDA 21–551) was approved on September 24, 2007. Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) was indicated for the cleansing of the colon as preparation for colonoscopy in adults. Braintree informed FDA that it ceased to manufacture and market Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) as of July 17, 2010. The drug product was then moved to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. FDA has reviewed its records concerning the withdrawal of Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl). FDA has also independently evaluated relevant literature, data from clinical trials, and E:\FR\FM\17AUN1.SGM 17AUN1 51038 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices reports of possible postmarketing adverse events. FDA has determined, under § 314.161, that Halflytely and Bisacodyl Tablets Bowel Prep Kit (10mg bisacodyl) was withdrawn from sale for reasons of safety or effectiveness. Braintree discontinued this product containing a total dose of 10 milligrams of bisacodyl from sale after receiving approval from FDA on July 16, 2010, for NDA 21–551/S–013, Halflytely and Bisacodyl Tablets Bowel Prep Kit (PEG– 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and one bisacodyl delayed release tablet, 5 mg (5-mg bisacodyl)). The data available from a clinical study comparing the 10-mg version of Halflytely and Bisacodyl Tablets Bowel Prep Kit to a 5-mg version of the drug product showed that the Halflytley and Bisacodyl Tablets Bowl Prep Kit (5-mg bisacodyl) has comparable effectiveness to the 10-mg product and has a safety advantage over the 10-mg product because there is less abdominal fullness and cramping in the patients treated with the 5-mg product. Furthermore, the 10-mg product may be associated with ischemic colitis. FDA has also reviewed the latest approved labeling for the 10-mg product and has determined that it would need to be updated with additional safety information if Braintree were to reintroduce the 10-mg product to the market. FDA has determined that additional clinical studies of safety and efficacy would be necessary before Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) could be considered for reintroduction to the market. Accordingly, the Agency will remove Halflytely and Bisacodyl Tablets Bowel Prep Kit (PEG–3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg) from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product. Dated: August 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. Emcdonald on DSK2BSOYB1PROD with NOTICES [FR Doc. 2011–20853 Filed 8–16–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES 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] Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled ‘‘Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)’’ dated July 2007. SUMMARY: DATES: August 17, 2011. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration (HFM–17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. In a notice published in the Federal Register of July 26, 2007 (72 FR 41080), FDA announced the availability of a draft guidance entitled ‘‘Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs).’’ SUPPLEMENTARY INFORMATION: FDA has carefully considered the comments received on the draft guidance and, since that document issued in 2007, has gained additional experience with point of care devices and the autologous cells selected by them. Based on these comments and experience, FDA believes that the draft guidance would not, if finalized in current form, reflect FDA’s current thinking. For these reasons, FDA is withdrawing the draft guidance entitled ‘‘Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs).’’ Dated: August 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–20862 Filed 8–16–11; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 18:13 Aug 16, 2011 Jkt 223001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Residual Drug in Transdermal and Related Drug Delivery Systems.’’ This guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and development—as well as during manufacturing and product life-cycle management—to ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The guidance is applicable to investigational new drug applications, new drug applications, abbreviated new drug applications, and supplemental new drug applications for TDDS, TMDS, and topical patch products. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Terrance Ocheltree, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 21, rm. 1609, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301– 796–1988. SUPPLEMENTARY INFORMATION: SUMMARY: E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51037-51038]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20853]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0507]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined that 
Halflytely and Bisacodyl Tablets Bowel Prep Kit (polyethylene glycol 
(PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride 
for oral solution and two bisacodyl delayed release tablets, 5 
milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons 
of safety or effectiveness. The Agency will not accept or approve 
abbreviated new drug applications (ANDAs) for bowel prep kits 
containing PEG-3350, sodium chloride, sodium bicarbonate, and potassium 
chloride for oral solution and two bisacodyl delayed release tablets, 5 
mg.

FOR FURTHER INFORMATION CONTACT: 
    Nikki Mueller, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6312, 
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 (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 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 (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, drugs are 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)(1) (21 CFR 
314.161(a)(1)), the Agency must determine whether a listed drug was 
withdrawn from sale for reasons of safety or effectiveness before an 
ANDA that refers to that listed drug may be approved. FDA may not 
approve an ANDA that does not refer to a listed drug.
    On September 23, 2010, FDA received a citizen petition (Docket No. 
FDA-2010-P-0507), submitted under Sec.  10.30 (21 CFR 10.30), from 
Perrigo Company (Perrigo). The petition requests that the Agency 
determine whether Halflytely and Bisacodyl Tablets Bowel Prep Kit (PEG-
3350, sodium chloride, sodium bicarbonate, and potassium chloride for 
oral solution and two bisacodyl delayed release tablets, 5 mg) 
(Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl)), 
manufactured by Braintree Laboratories, Inc. (Braintree), was withdrawn 
from sale for reasons of safety or effectiveness.
    Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) 
(NDA 21-551) was approved on September 24, 2007. Halflytely and 
Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) was indicated for 
the cleansing of the colon as preparation for colonoscopy in adults. 
Braintree informed FDA that it ceased to manufacture and market 
Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) as of 
July 17, 2010. The drug product was then moved to the ``Discontinued 
Drug Product List'' section of the Orange Book.
    FDA has reviewed its records concerning the withdrawal of 
Halflytely and Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl). FDA 
has also independently evaluated relevant literature, data from 
clinical trials, and

[[Page 51038]]

reports of possible postmarketing adverse events. FDA has determined, 
under Sec.  314.161, that Halflytely and Bisacodyl Tablets Bowel Prep 
Kit (10-mg bisacodyl) was withdrawn from sale for reasons of safety or 
effectiveness.
    Braintree discontinued this product containing a total dose of 10 
milligrams of bisacodyl from sale after receiving approval from FDA on 
July 16, 2010, for NDA 21-551/S-013, Halflytely and Bisacodyl Tablets 
Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate, and 
potassium chloride for oral solution and one bisacodyl delayed release 
tablet, 5 mg (5-mg bisacodyl)). The data available from a clinical 
study comparing the 10-mg version of Halflytely and Bisacodyl Tablets 
Bowel Prep Kit to a 5-mg version of the drug product showed that the 
Halflytley and Bisacodyl Tablets Bowl Prep Kit (5-mg bisacodyl) has 
comparable effectiveness to the 10-mg product and has a safety 
advantage over the 10-mg product because there is less abdominal 
fullness and cramping in the patients treated with the 5-mg product. 
Furthermore, the 10-mg product may be associated with ischemic colitis.
    FDA has also reviewed the latest approved labeling for the 10-mg 
product and has determined that it would need to be updated with 
additional safety information if Braintree were to reintroduce the 10-
mg product to the market. FDA has determined that additional clinical 
studies of safety and efficacy would be necessary before Halflytely and 
Bisacodyl Tablets Bowel Prep Kit (10-mg bisacodyl) could be considered 
for reintroduction to the market. Accordingly, the Agency will remove 
Halflytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium 
chloride, sodium bicarbonate, and potassium chloride for oral solution 
and two bisacodyl delayed release tablets, 5 mg) from the list of drug 
products published in the Orange Book. FDA will not accept or approve 
ANDAs that refer to this drug product.

    Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20853 Filed 8-16-11; 8:45 am]
BILLING CODE 4160-01-P

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