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US FDA source recordCRL · Complete Response Letter

NORTHERA — FDA Complete Response Letter (NDA 203202)

Issued to Chelsea Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.

Issued

March 28, 2012

Application

NDA 505b1 • 203202

Product

NORTHERA

Company

Chelsea Therapeutics, Inc.

Stage

Final Decision

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What did FDA decide for NORTHERA?

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Source facts

FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

Key details in this letter

  • 1Clinical efficacy and substantial evidence: 17 source-text matches.
  • 2Labeling, packaging, and proprietary name: 8 source-text matches.
  • 3Safety and adverse events: 1 source-text match.
  • 4Chemistry, manufacturing, and controls: 1 source-text match.
Clinical efficacy and substantial evidenceLabeling, packaging, and proprietary nameSafety and adverse eventsChemistry, manufacturing, and controlsBioequivalence and pharmacokinetics

Suggested next step

Review the exact redacted FDA letter and address each stated deficiency before resubmission.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the NORTHERA complete response letter

What does this complete response letter mean for NORTHERA?

Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Chelsea Therapeutics, Inc. on March 28, 2012.

What is NDA 203202?

NDA 203202 is the application under which FDA issued this complete response letter for NORTHERA to Chelsea Therapeutics, Inc.. The letter is dated March 28, 2012.

What happens after an FDA complete response letter?

FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.