Approval Letter Other 210933 (Jan 1, 2021)

Summary

This document is an electronic record of an "OTHER ACTION LETTER" from the Center for Drug Evaluation and Research (CDER), associated with application number 210933Orig1s000, detailing its electronic signature.

Key points

• Record of an electronically signed document.
• Identification of Application Number 210933Orig1s000.
• Categorization as an 'OTHER ACTION LETTER'.
• Respond to agency requests within the prescribed timeline.

Cited reasons

• Agency deficiencies
• No specific deficiencies or findings are detailed in the provided truncated letter. The letter indicates an 'Other Action Letter' for an original submission, with an approval decision.

Recommended actions

• Record of an electronically signed document.
• Identification of Application Number 210933Orig1s000.
• Categorization as an 'OTHER ACTION LETTER'.

Deficiency summary

No specific deficiencies or findings are detailed in the provided truncated letter. The letter indicates an 'Other Action Letter' for an original submission, with an approval decision.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

Unknown

Impact

Impact score

0.75

Estimated delay

180 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The letter is an 'Other Action Letter' for an original submission, with an approval decision, but lacks specific details regarding the product or the nature of the action beyond approval.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%