[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Withdrawn From Sale for Reasons of Safety or Effectiveness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(mg) (20-mg bisacodyl)) was withdrawn from sale for reasons of safety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