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  5. Exhibit 4-5 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-5 long description

Product A submitted the CMC Reviewable Unit (RU) 12 months prior to the complete submission and the Discipline Review (DR) letter was issued at 6 months, the P/T RU was submitted 7 months early and the DR letter issued at 6 months, and an approvable letter issued 6 months after the complete submission. Product B had the P/T RU submitted 5 months early, the clinical RU submitted 3 months early, both received DR letters within 6 months, and an approval letter was issued following a 3 month extension. Product C submitted a P/T RU 5 months prior to the complete submission (DR letter issued in 5.3 months) and the application received an approval at 6 months. Product D submitted the CMC RU 4.5 months early (DR letter issued at 6 months), the P/T RU 4 months early (DR letter issued at 6 months), the Bio/Pharm RU 1.5 months early (DR letter 5.9 months), and a not approvable letter was issued 6 months after complete submission. Product E submitted the CMC RU 4 months prior to complete submission (DR letter issued at 5.9 months) and an approval action taken at 6 months. Product F submitted the P/T RU 2 months early (DR letter in 6 months), the CMC RU 1.5 months early (DR letter in 5.7 months), the application received a standard review with a clock extension at 9 months with an approvable letter issued. Product G submitted the Clinical, P/T, and Bio/Pharm RUs 3 months early, DR letters were issued in 6 months and the application received an approval at 6 months. Product H submitted the CMC and P/T RUs 1.5 months early with DR letters issued in 4.8 months and the product was approved 4 months after complete submission. Product I submitted the P/T RU 1 month early, received DR letter in 6 months and an approval letter 6 months after complete submission. Product J submitted the P/T 3 months early, the clinical 1.5 months early and the CMC RU 1 month early, all received DR letters in 6 months and an approval action was taken at 6 months.

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