FDAsafety guidance66% confidence
FDA AP — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Micro Labs; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA219869. Sponsor: HETERO LABS LTD V. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM.
Supporting Context
- Therapeutic area
- Cardiovascular · Antihypertensive
- Sub-indication
- General
Related signal: FDA Approval Status Update for Losartan Potassium by Micro Labs