First-time generic approvals
First-time generic approvals
Valacyclovir tablets, 500 mg (base) and 1 g (base) (equiv to Valtrex caplets)
RANBAXY
Albuterol sulfate extended-release tablets, 4 mg (base) and 8 mg (base) (equiv to VoSpire ER tablets)
MYLAN
Fentanyl-12 transdermal system, 12.5 mcg/h (equiv to Duragesic-12)
MYLAN
Dexmethylphenidate tablets, 2.5, 5, and 10 mg (equiv to Focalin tablets)
TEVA
FDA Expands Kerendia’s Use to Treat Common Form of Heart Failure
July 14th 2025Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.
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