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15632 Federal Register / Vol. 70, No.

58 / Monday, March 28, 2005 / Notices


No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours

211.194 4,184 25 104,600 .5 52,300

211.196 4,184 25 104,600 .25 26,150

211.198 4,184 5 20,920 1 20,920

211.204 4,184 10 41,840 .5 20,920

Total 848,625
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 21, 2005. which is typically a version of the drug CFR 10.30, requesting that the agency
Jeffrey Shuren, that was previously approved. Sponsors determine whether ACIPHEX delayed-
Assistant Commisssioner for Policy. of ANDAs do not have to repeat the release tablets, 10 mg, were withdrawn
[FR Doc. 05–5976 Filed 3–25–05; 8:45 am] extensive clinical testing otherwise from sale for reasons of safety or
BILLING CODE 4160–01–S necessary to gain approval of a new effectiveness.
drug application (NDA). The only The agency has determined that
clinical data required in an ANDA are Eisai’s ACIPHEX delayed-release tablets,
DEPARTMENT OF HEALTH AND data to show that the drug that is the 10 mg, were not withdrawn from sale
HUMAN SERVICES subject of the ANDA is bioequivalent to for reasons of safety or effectiveness.
the listed drug. ACIPHEX delayed-release tablets, 10
Food and Drug Administration The 1984 amendments include what
mg, were approved on May 29, 2002,
[Docket No. 2004P–0285]
is now section 505(j)(7) of the Federal
and Eisai has never commercially
Food, Drug, and Cosmetic Act (21 U.S.C.
marketed the 10-mg dose. In previous
Determination That ACIPHEX 355(j)(7)), which requires FDA to
instances (see the Federal Register of
(Rabeprazole Sodium) Delayed- publish a list of all approved drugs.
December 30, 2002 (67 FR 79640 at
Release Tablets, 10 Milligrams, Were FDA publishes this list as part of the
79641) (addressing a relisting request for
Not Withdrawn From Sale for Reasons ‘‘Approved Drug Products With
Diazepam Autoinjector)), FDA has
of Safety or Effectiveness Therapeutic Equivalence Evaluations,’’
concluded that, for purposes of
which is generally known as the
AGENCY: Food and Drug Administration, §§ 314.161 and 314.162, never
‘‘Orange Book.’’ Under FDA regulations,
HHS. marketing an approved drug product is
drugs are withdrawn from the list if the
ACTION: Notice. equivalent to withdrawing the drug
agency withdraws or suspends approval
from sale. There is no indication that
SUMMARY: The Food and Drug
of the drug’s NDA or ANDA for reasons
Eisai’s decision not to market ACIPHEX
Administration (FDA) has determined of safety or effectiveness, or if FDA
delayed-release tablets, 10 mg,
that ACIPHEX (rabeprazole sodium) determines that the listed drug was
commercially is a function of safety or
delayed-release tablets, 10 milligrams withdrawn from sale for reasons of
effectiveness concerns, and the
(mg), were not withdrawn from sale for safety or effectiveness (§ 314.162 (21
petitioner has identified no data or other
reasons of safety or effectiveness. This CFR 314.162)).
Under § 314.161(a)(1) (21 CFR information suggesting that ACIPHEX
determination will allow FDA to delayed-release tablets, 10 mg, pose a
314.161(a)(1)), the agency must
approve abbreviated new drug safety risk. FDA’s independent
determine whether a listed drug was
applications (ANDAs) for rabeprazole evaluation of relevant information has
withdrawn from sale for reasons of
sodium delayed-release tablets, 10 mg. uncovered nothing that would indicate
safety or effectiveness before an ANDA
that refers to that listed drug may be that this product was withdrawn for
Elizabeth Sadove, Center for Drug approved. FDA may not approve an reasons of safety or effectiveness.
Evaluation and Research (HFD–7), Food ANDA that does not refer to a listed After considering the citizen petition
and Drug Administration, 5600 Fishers drug. and reviewing agency records, FDA
Lane, Rockville, MD 20857, 301–594– ACIPHEX delayed-release tablets are determines that for the reasons outlined
2041. the subject of approved NDA 20–973 previously, ACIPHEX delayed-release
SUPPLEMENTARY INFORMATION: In 1984, held by Eisai, Inc. (Eisai). ACIPHEX tablets, 10 mg, were not withdrawn from
Congress enacted the Drug Price (rabeprazole sodium) delayed-release sale for reasons of safety or
Competition and Patent Term tablets are a proton pump inhibitor effectiveness. Accordingly, the agency
Restoration Act of 1984 (Public Law 98– indicated for the healing of erosive or will continue to list ACIPHEX
417) (the 1984 amendments), which ulcerative gastroesophageal reflux (rabeprazole sodium) delayed-release
authorized the approval of duplicate disease (GERD), maintenance of healing tablets, 10 mg, in the ‘‘Discontinued
versions of drug products approved of erosive GERD, healing of duodenal Drug Product List’’ section of the Orange
under an ANDA procedure. ANDA ulcers, and treatment of pathological Book. The ‘‘Discontinued Drug Product
sponsors must, with certain exceptions, hypersecretory conditions, including List’’ delineates, among other items,
show that the drug for which they are Zollinger-Ellison Syndrome. Lachman drug products that have been
seeking approval contains the same Consultant Services, Inc., submitted a discontinued from marketing for reasons
active ingredient in the same strength citizen petition dated July 6, 2004 other than safety or effectiveness.
and dosage form as the ‘‘listed drug,’’ (Docket No. 2004P–0285/CP1), under 21 ANDAs that refer to ACIPHEX delayed-

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Federal Register / Vol. 70, No. 58 / Monday, March 28, 2005 / Notices 15633

release tablets, 10 mg, may be approved MD 20852. Submit electronic comments currently approved labeling to include
by the agency. to directions for using the two products
Dated: March 17, 2005. ecomments. together. When sponsors work together
Jeffrey Shuren, FOR FURTHER INFORMATION CONTACT: to develop mutually conforming
For information about the public labeling, they usually have an ongoing
Assistant Commissioner for Policy.
meeting contact: Suzanne O’Shea, relationship that enables them to resolve
[FR Doc. 05–5975 Filed 3–25–05; 8:45 am] scientific or legal issues that may arise
Office of Combination Products,
Food and Drug Administration as a result of the two products being the
(HFG–3), suite 200, 15800 Crabbs responsibility of two independent
Branch Way, Rockville, MD 20855, sponsors. For this reason, FDA
DEPARTMENT OF HEALTH AND encourages sponsors to work together as
HUMAN SERVICES 301–427–1934, FAX: 301–427–
1935, e-mail: much as possible when bringing to
Food and Drug Administration To register to speak at the public market independently developed,
meeting contact: Amanda Carmody, manufactured, and distributed products
[Docket No. 2005N–0098] Drug Information Association, P.O. that are intended to be used together.
Box 827192, Philadelphia, PA On occasion, however, the two
Food and Drug Administration/Drug sponsors do not work together, and the
19182–7192, e-mail:
Information Association Cross, or sponsor of a new product unilaterally
Labeling; Public Meeting; Combination 215–442–6176. develops a product intended to be used
Products and Mutually Conforming with an already approved or cleared
Labeling product. The sponsor of the new
I. Background product is frequently willing to develop
AGENCY: Food and Drug Administration,
HHS. An increasing number of combined data demonstrating the safe and
uses for drugs and devices, drugs and effective use of both products used
ACTION: Notice of public meeting;
biological products, or devices and together. When the new product is
request for comments.
biological products are being developed intended to be used with the approved
SUMMARY: The Food and Drug where the two products are product in a way that is significantly
Administration (FDA), in cooperation independently approved, manufactured, different from ways described in the
with the Drug Information Association and distributed. In some cases, when current labeling of the approved product
(DIA), is announcing a public meeting to one product is already approved for a (e.g., for a different indication, route of
solicit views and provide an interactive particular indication, route of administration or dose), refusal by the
forum for discussion of stakeholders’ administration or dose, another sponsor sponsor of the approved product to
perspectives about, and experiences may develop a separate product to be submit a supplement2 may preclude
with, the legal and public health issues used with the approved product for an mutually conforming labeling. In some
that arise when sponsors seek to indication, route of administration or cases, when the two sponsors do not
develop or market a product of one type dose different from the one specified in work together, requiring that the two
(device, drug, or biological product) that the current labeling of the approved products have mutually conforming
would be labeled for use with an product. Frequently, the sponsors of the labeling could prevent the development
already approved product of a different two products work together to develop of new products. FDA is concerned that
type, and the approved product’s safety and effectiveness data and to valuable products may not be
labeling would not be changed. The bring the two products to market with developed, manufactured, or distributed
input received at the meeting and mutually conforming labeling, i.e., because of sponsor concerns about
comments made to the docket after the labeling for each product that provides mutually conforming labeling.
meeting will be considered in directions for using that product with Therefore, FDA is considering
developing draft guidance on this topic. the other sponsor’s product. In such whether the agency should review and
cases, the two products are considered approve or clear drug-device, biologic-
DATES: The public meeting will be held
a combination product under § 3.2(e)(3) device, or drug-biologic products,
on May 10, 2005, from 8:30 a.m. to 5
(21 CFR 3.2(e)(3)), which states that a where:
p.m. Attendees must register to attend.
combination product includes: • One sponsor’s new product is
Submit written or electronic requests to
A drug, device, or biological product intended for use with another sponsor’s
speak at the public meeting by April 26,
packaged separately that according to its approved or cleared product;
2005. Submit written or electronic investigational plan or proposed labeling is • The approved or cleared product
comments by July 8, 2005. intended for use only with an approved would be used in a way that is
ADDRESSES: The public meeting will be individually specified drug, device, or significantly different from the use
held at the Bethesda North Marriott biological product where both are required to described in its current labeling, e.g., a
Hotel & Conference Center, 5701 achieve the intended use, indication, or effect
and where upon approval of the proposed
different indication, route of
Marinelli Rd., North Bethesda, MD. A administration, or dose;
product the labeling of the approved product
copy of the meeting’s program and would need to be changed, e.g., to reflect a • Data are available to demonstrate
registration information is available on change in intended use, dosage form, the safe and effective use of the two
the Internet at strength, route of administration, or products together;
Content/Events/05028.pdf, by significant changed in dose* * *. • There is no cooperation, ongoing
contacting the Drug Information In order for the two products to have relationship, or right of reference
Association, P.O. Box 827192, mutually conforming labeling of the between the sponsors of the two
Philadelphia, PA 19182–7192, or 215– type contemplated by § 3.2(e)(3), the products; and
442–6100. sponsor of the approved product • The sponsor of the new product
Submit written comments to the ordinarily must submit a supplement to asks FDA to review the new product for
Division of Dockets Management (HFA– its marketing application1 to amend the use with the approved product under
305, Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, 1 In some cases, a new 510(k) might be required. 2 Or in some cases, a new 510(k).

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