[Federal Register Volume 75, Number 53 (Friday, March 19, 2010)]
[Notices]
[Page 13292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0412]


Determination That HalfLytely and Bisacodyl Tablets Bowel Prep 
Kit (Containing 4 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 4 bisacodyl delayed release tablets, 5 milligrams 
(mg) (20-mg bisacodyl)) was withdrawn from sale for reasons of safety 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 4 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 (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 (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 July 15, 2008, FDA received a citizen petition (Docket No. FDA-
2008-P-0412), submitted under 21 CFR 10.30, from Foley & Lardner LLP. 
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 4 bisacodyl 
delayed release tablets, 5 mg) (HALFLYTELY AND BISACODYL TABLETS BOWEL 
PREP KIT (20-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 (20-mg bisacodyl) 
(NDA 21-551) was approved on May 10, 2004. HALFLYTELY AND BISACODYL 
TABLETS BOWEL PREP KIT (20-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 (20-mg bisacodyl) as of 
September 25, 2007. 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 (20-mg bisacodyl). FDA 
has also independently evaluated relevant literature, data from 
clinical trials, and reports of possible postmarketing adverse events. 
FDA has determined, under Sec.  314.161, that HALFLYTELY AND BISACODYL 
TABLETS BOWEL PREP KIT (20-mg bisacodyl) was withdrawn from sale for 
reasons of safety or effectiveness.
    Braintree discontinued this product containing a total dose of 20 
milligrams of bisacodyl from sale after receiving approval from FDA on 
September 24, 2007, for HALFLYTELY AND BISACODYL TABLETS BOWEL PREP KIT 
(PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride 
for oral solution and 2 bisacodyl delayed release tablets, 5 mg (10-mg 
bisacodyl)). The data available from multiple clinical studies show 
that the HALFLYTLEY AND BISACODYL TABLETS BOWL PREP KIT (10-mg 
bisacodyl) has comparable effectiveness to the 20-mg product and has a 
safety advantage over the 20-mg product because there is less nausea 
and abdominal cramping in the patients treated with the 10-mg product. 
Furthermore, the 20-mg product may be associated with ischemic colitis.
    FDA has also reviewed the latest approved labeling for the 20-mg 
product and has determined that it would need to be updated with 
additional safety information if Braintree were to reintroduce the 20-
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 (20-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 4 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: March 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5979 Filed 3-18-10; 8:45 am]
BILLING CODE 4160-01-S