Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Cecelia M. Parise,Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857, 301–827–5845.
In the
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petition no. 94P–0199/CP1 before April 1, 1999; therefore, approval of this suitability petition should not have been withdrawn.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
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.