The US Food and Drug Administration (FDA) has granted final approval to Breckenridge Pharmaceutical Inc, a subsidiary of Laboratorios Pen, SA, for its Abbreviated New Drug Application (ANDA) for Asenapine Sublingual Tablets in 2.5mg and 10mg strengths (generic for Saphris), it was reported on Friday.
Breckenridge Pharmaceutical is planning to introduce these strengths immediately.
The FDA has granted tentative approval for the 5mg strength. The product was developed in partnership with MSN Laboratories Private Limited. The product is intended for the treatment of mental/mood disorders.
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