FDA approves ANDA of 20mg generic Nitisinone capsules
Betsy Goodfellow | June 1, 2023 | News story | Medical Communications | Analog Pharma, Dipharma, FDA, Nitisinone, Rare Diseases
Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has approved their 20mg nitisinone capsules, a generic equivalent of Swedish Orphan Biovitrum’s Orfadin. Analog already distributed the 2mg, 5mg and 10mg doses.
Nitisinone capsules are used in the treatment of adult and paediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Tanya Carro, executive vice president of Analog Pharma, commented: “With the approval of the 20mg capsule, we now have a full complement of room temperature stable strengths for our generic Nitisinone. Considering that the 20mg is the most commonly prescribed strength of Orfadin, this will bring American patients with HT-1 a room temperature-stable treatment option. The addition of this new dosage form to our portfolio demonstrates our continued commitment to offering high quality, cost-effective generic drugs for the treatment of rare diseases.”
Marc-Oliver Geinoz, Dipharma’s CEO, added: “We are pleased to announce that the FDA has now approved our 20mg Nitisinone capsules. For the first time, American HT-1 patients will have access to 20mg capsules which are stable at room temperature for three years. This is the result of the collaboration between Dipharma and our American partner Analog Pharma, which achieved this milestone ahead of time: our next milestone for this year is to extend – from two to three years ‒ the stability at room temperature of the lower strength capsules as well. Dipharma is a pioneer in developing improved generic pharmaceutical products for rare diseases: our desire to innovate and our engagement do not stop, but every day we continue to seek new and better solutions for patients around the world.”
Betsy Goodfellow
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