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 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.