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


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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Was Withdrawn From Sale for Reasons of Safety or Effectiveness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.

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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milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons 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