[Federal Register Volume 72, Number 150 (Monday, August 6, 2007)]
[Notices]
[Pages 43643-43644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15172]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006P-0287 and 2006P-0399]
Determination That PHOSLO (Calcium Acetate) 667-Milligram Tablet
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
PHOSLO (calcium acetate) 667-milligram (mg) tablet, equal to 169 mg
calcium, was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for calcium acetate 667-mg tablet.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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
sponsors 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. Sponsors of ANDAs 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 Under FDA regulations, drugs are withdrawn from the list if the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drug was withdrawn from sale for reasons of safety or effectiveness (21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
[[Page 43644]]
ANDA that does not refer to a listed drug.
PHOSLO (calcium acetate) 667-mg tablet, equal to 169 mg calcium, is
the subject of approved NDA 19-976 held by Fresenius Medical Care
(Fresenius). PHOSLO (calcium acetate) 667-mg tablet is indicated for
the control of hyperphosphatemia in end stage renal failure.
Fresenius's NDA 19-976 was approved on December 10, 1990. Lachman
Consultant Services, Inc., and Beckloff Associates, submitted citizen
petitions dated July 14, 2006 (Docket No. 2006P-0287/CP1) and September
27, 2006 (Docket No. 2006P-0399), respectively, under 21 CFR 10.30,
requesting that the agency determine, as described in Sec. 314.161,
whether PHOSLO (calcium acetate) 667-mg tablet was withdrawn from sale
for reasons of safety or effectiveness.
The agency has determined that Fresenius's PHOSLO (calcium acetate)
667-mg tablet was not withdrawn from sale for reasons of safety or
effectiveness. FDA has reviewed its files for records concerning the
withdrawal of PHOSLO (calcium acetate) 667-mg tablet from sale. There
is no indication that the decision to discontinue marketing of PHOSLO
(calcium acetate) 667-mg tablet was a function of safety or
effectiveness concerns, and the petitioner has identified no data or
information suggesting that PHOSLO (calcium acetate) 667-mg tablet was
withdrawn for safety or effectiveness reasons. FDA has independently
evaluated relevant literature and data for adverse event reports and
has found no information that would indicate that PHOSLO (calcium
acetate) 667-mg tablet was withdrawn for reasons of safety or
effectiveness.\1\
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\1\Beckloff Associates also requested that the agency determine
whether PHOSLO (calcium acetate) 667-mg capsule was withdrawn from
sale for reasons of safety or effectiveness. Because a capsule
dosage form for this product is currently marketed, such a
determination is not necessary (See NDA 21-160, product no. 3).
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After considering the citizen petitions and reviewing agency
records, FDA determines that for the reasons outlined in this document,
PHOSLO (calcium acetate) 667-mg tablet was not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will
continue to list PHOSLO (calcium acetate) 667-mg tablet in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to PHOSLO (calcium
acetate) 667-mg tablet may be approved by the agency as long as they
meet all relevant legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for these drug products should
be revised to meet current standards, the agency will advise ANDA
applicants to submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15172 Filed 8-3-07; 8:45 am]
BILLING CODE 4160-01-S >