Lilly wins two label supplements: orforglipron tablet and teriparatide solution
Eli Lilly received FDA approval for supplemental applications covering the FOUNDAYO orforglipron tablet and FORTEO teriparatide subcutaneous solution.
Two labeling supplements for Eli Lilly products cleared FDA review this week.
- FOUNDAYO, an oral tablet with orforglipron calcium as the active ingredient, received approval for its third labeling supplement under NDA220934, sponsored by Eli Lilly and Co, with a submission status date of August 4, 2026.1 The approved product strengths span 0.8MG, 2.5MG, 5.5MG, 9MG, 14.5MG, and 17.2MG base.1
- Teriparatide, marketed as FORTEO by Lilly, is a subcutaneous solution that received approval for its 59th labeling supplement under NDA021318, with a submission status date of August 3, 2026.2 The update covers dosage strengths of 0.56MG/2.24ML and 0.75MG/3ML.2
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