Breyna is a metered-dose inhaler containing budesonide, a corticosteroid, and formoterol, a long-acting bronchodilator.
The approval is only for the drug cartridges, which are compatible for use with the Apokyn Pen, the brand name pen injector.
Betaine Anhydrous Powder is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations.
Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Glycopyrrolate Oral Solution is supplied as 1mg/5mL in a 16oz bottle.
Rezvoglar is a long-acting human insulin analogue.
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.
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