Clinical and Summary Information

v      Summary Reviews (e.g., Office Director, Division Director, Medical Team Leader) (indicate date for each review)

TL Memo/ 8-21-03

v      Clinical review(s) (indicate date for each review)

8/21/03

v      Microbiology (efficacy) review(s) (indicate date for each review)

N/A

v      Safety Update review(s) (indicate date or location if incorporated in another review)

See clinical review 8/21/03

v      Pediatric Page (separate page for each indication addressing status of all age groups)

See Tab G

v      Statistical review(s) (indicate date for each review)

N/A

v      Biopharmaceutical review(s) (indicate date for each review)

7/30/03

v      Controlled Substance Staff review(s) and recommendation for scheduling (indicate date for each review)

N/A

v      Clinical Inspection Review Summary (DSI)

See AE Package

·         Clinical studies

·         Bioequivalence studies

CMC Information

v      CMC review(s) (indicate date for each review)

8/15/03

v      Environmental Assessment

·         Categorical Exclusion (indicate review date)

See AE Package Tab Q

·         Review & FONSI (indicate date of review)

See AE Package Tab Q

·         Review & Environmental Impact Statement (indicate date of each review)

See AE Package Tab Q

v      Micro (validation of sterilization & product sterility) review(s) (indicate date for each review)

N/A

v      Facilities inspection (provide EER report)

Date completed:

(x) Acceptable – completed 7/31/03

( ) Withhold recommendation

v      Methods validation

( ) completed

(x) requested

( ) Not yet requested

Nonclinical Pharm/Tox Information

v      Pharm/tox review(s), including referenced IND reviews (indicate date for each review)

N/A

v      Nonclinical inspection review summary

N/A

v      Statistical review(s) of carcinogenicity studies (indicate date for each review)

N/A

v      CAC/ECAC report

N/A