[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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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calcium, was not withdrawn from sale for reasons of safety or 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 Under FDA regulations, drugs are withdrawn from the list if the 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 >