FDAsafety guidance77% confidence
FDA AP — SOLRIAMFETOL HYDROCHLORIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Hospira; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA218722. Sponsor: ALKEM LABS LTD. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: SOLRIAMFETOL HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Anesthesia · Local Anesthetic
- Sub-indication
- General
Related signal: FDA Grants AP Status for Lidocaine Hydrochloride ANDA040078