Generics News

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.

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.