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June 01, 2023
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FDA approves 20 mg nitisinone capsules for hereditary tyrosinemia

Key takeaways:

  • Capsules are a generic equivalent of Swedish Orphan Biovitrum’s Orfadin.
  • Analog Pharma also distributes 2 mg, 5 mg and 10 mg capsules through specialty pharmacies.

The FDA has approved the 20 mg version of nitisinone used to treat hereditary tyrosinemia, according to a press release.

Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor developed by Analog Pharma, which also distributes 2 mg, 5 mg and 10 mg capsules through specialty pharmacies.

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“With the approval of the 20 mg capsule, we now have a full complement of room temperature stable strengths for our generic Nitisinone,” Tanya Carro, executive vice president of Analog, said in the release. “Considering that the 20 mg is the most commonly prescribed strength of Orfadin, this will bring American patients with hereditary tyrosinemia type-1 (HT-1) a room temperature stable, treatment option.”

Nitisinone capsules are a room temperature stable, AB-rated, generic equivalent of Orfadin (Swedish Orphan Biovitrum). The drug treats adult and pediatric patients with hereditary HT-1 in combination with dietary restriction of tyrosine and phenylalanine, according to the release.

“This is the result of the collaboration between Dipharma and our American partner Analog Pharma, which achieved this milestone ahead of time,” Marc-Olivier Geinoz, CEO of Dipharma, said in the release. “Our next milestone for this year is to extend – from 2 to 3 years – the stability at room temperature of the lower strength capsules as well.”