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. Nitisinone capsules are indicated for the treatment of adult and paediatric patients with HT-1 in combination with dietary restriction of tyrosine and phenylalanine.
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