Sanofi (NYSE:SNY) said today that the FDA granted the company tentative approval for its Admelog insulin lispro injection.
The decision is based on physicochemical, non-clinical and clinical similarity to another, already-approved insulin lispro injection. The compound is contraindicated during hypoglycemia episodes and in patients with hypersensitivity to insulin lispro or one of its other ingredients, Sanofi said.
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