[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]
-----------------------------------------------------------------------
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Was Withdrawn From Sale for Reasons of Safety or Effectiveness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milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons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