Carglumic acid is a carbamoyl phosphate synthetase 1 activator.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
Semglee and Insulin Glargine may now be substituted for the reference product Lantus (insulin glargine) at the pharmacy counter.
The Company also received tentative approval for the 5mg, 10mg, 15mg, and 25mg strengths.
Clindamycin phosphate EQ 1% gel is indicated for topical application in the treatment of acne vulgaris.
Semglee (insulin glargine) may be substituted for the reference product, Lantus, at the pharmacy counter and without the intervention of the prescriber.
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