The approval of the new citrate-free, high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study.
Emzahh is an AB-rated generic equivalent of Ortho Micronor.
The approval was granted Competitive Generic Therapy exclusivity meaning the Company will have 180 days exclusivity.
Haloette is an estrogen/progestin combination hormonal contraceptive.
Romidepsin is a histone deacetylase inhibitor indicated for the treatment of cutaneous T-cell lymphoma.
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
The generic version is available in 2 dosage strengths.
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.
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