FDA approves Analog and Dipharma’s ANDA for nitisinone capsules
Pharmaceutical Technology
JUNE 1, 2023
The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.
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