US-based Breckenridge Pharmaceutical Inc, a subsidiary of Towa Pharmaceutical, announced on Tuesday that it has been granted final approval from the United States Food and Drug Administration (FDA) for its Everolimus Tablets (generic for Zortress).
The product was produced in partnership with Natco Pharma Limited. The company is planning to launch Everolimus Tablets in 0.25mg, 0.5mg and 0.75mg strengths during the third quarter of 2021 in a blister card packaging configuration.
According to industry sales data, Zortress and its therapeutic equivalents generated USD162 million in annual sales for the twelve months ending March 2021.
Apotex launches Teriparatide Injection in US
Teva Pharmaceuticals secures FDA approval for generic Forteo (teriparatide injection)
Upsher-Smith Laboratories introduces Pitavastatin Tablets
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Sanofi and Teva collaborate on innovative IBD treatment
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling