Generics News

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 for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.

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.