Generics
US FDA grants approval to Novitium Pharma's Biovitrum's Orfadin
6 September 2019 -

The US Food and Drug Administration (FDA) has granted approval to Novitium Pharma, the partner of an Endo International subsidiary, for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules), it was reported yesterday.

Endo's operating company, Par Pharmaceutical Inc, is likely to distribute the product through specialty pharmacies starting this month.

Nitisinone capsules are intended for the treatment of adult and paediatric patients with hereditary tyrosinemia type 1 (HT-1), in combination with dietary restriction of tyrosine and phenylalanine.

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