[Federal Register Volume 73, Number 195 (Tuesday, October 7, 2008)]
[Notices]
[Page 58606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23721]



[[Page 58606]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-P-0474] (formerly Docket No. 2004P-0262)


Withdrawal of Approval of 128 Suitability Petitions; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of February 23, 2007 (72 FR 
8184). The notice announced that FDA was withdrawing approval of 128 
suitability petitions in accordance with the Pediatric Research Equity 
Act of 2003 (PREA). FDA has determined that approval of the suitability 
petition submitted by Roxane Laboratories, Inc. (Roxane), for lorazepam 
oral solution, 1 milligram (mg)/10 milliliters (mL) (Docket No. FDA-
1994-P-0017),\1\ should not have been withdrawn and therefore 
retroactively reinstates its approval of that petition. This document 
also corrects errors in the petition numbers for two of the suitability 
petitions listed in the notice.
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    \1\ This citizen petition was originally assigned docket number 
94P-0199. The number was changed to FDA-1994-P-0017 as a result of 
FDA's transition to its new docketing system (http://www.Regulations.gov) in January 2008.

FOR FURTHER INFORMATION CONTACT: Cecelia M. Parise,Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration,5600 
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Fishers Lane, Rockville, MD 20857, 301-827-5845.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 23, 2007 
(72 FR 8184), FDA announced that it was withdrawing approval of 128 
suitability petitions in accordance with PREA. Prior to PREA's 
enactment, FDA had approved these suitability petitions to permit 
abbreviated new drug applications (ANDAs) to be submitted for drugs 
that had a different active ingredient, dosage form, or route of 
administration than their reference listed drugs. In the notice, FDA 
explained that the approval of these suitability petitions was being 
withdrawn because ANDAs were never submitted and PREA requires that all 
applications submitted on or after April 1, 1999, for a new active 
ingredient, new indication, new dosage form, new dosing regimen, or new 
route of administration contain an assessment of the safety and 
effectiveness of the drug for the claimed indications in relevant 
pediatric subpopulations unless the requirement is waived or deferred. 
Thus, these suitability petitions no longer satisfied the conditions 
for approval. The notice became effective on March 26, 2007.
    In response to the notice, Roxane sent FDA a letter dated March 1, 
2007, regarding the withdrawal of approval of its suitability petition 
for lorazepam oral solution, 1 mg/10 mL (Docket No. FDA-1994-P-0017). 
Roxane stated that it submitted ANDA 74-648 for lorazepam oral 
solution, 1 mg/10 mL, on the basis of the approval of its suitability 
petition for lorazepam oral solution, 1 mg/10 mL (Docket No. FDA-1994-
P-0017). Roxane also stated that during the review of the ANDA, they 
were asked to change the name of the product to lorazepam oral 
solution, 0.5 mg/5 mL, and the ANDA was approved on March 18, 1997. FDA 
has reviewed its records and determined that ANDA 74-648 was submitted 
under suitability petition no. 94P-0199/CP1 before April 1, 1999; 
therefore, approval of this suitability petition should not have been 
withdrawn. This document corrects the error and retroactively 
reinstates approval of the suitability petition for lorazepam oral 
solution, 1 mg/10 mL (Docket No. FDA-1994-P-0017).
    In addition, FDA has determined that the notice contained incorrect 
petition numbers for two of the suitability petitions. This document 
corrects those errors.
    In FR Doc. E7-3043, appearing on page 8184 in the Federal Register 
of Friday, February 23, 2007, the following corrections are made:
    1. On page 8185, in the table, in the first column, for Petition 
No., ``85P-0095/CP1'' is corrected to read ``83N-0095/CP1''.
    2. On page 8187, in the table, in the first column, for Petition 
No., ``92P-0332/CP1'' is corrected to read ``92P-0232/CP1''.
    3. On page 8187, in the table, in the first column, for Petition 
No., ``94P-0199/CP1'' is deleted.

    Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23721 Filed 10-6-08; 8:45 am]
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