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Analog Pharma und Dipharma geben die Genehmigung der US FDA für einen abgekürzten Antrag auf ein neues Medikament (ANDA) für 20 mg generische Nitisinon-Kapseln (Temperaturstabil) bekannt.

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Ursula Gerhards
31 Mai 2023

Princeton, NJ and Chiasso, Switzerland, May 31st, 2023 |

Analog Pharma (member of Duchesnay Pharmaceutical Group, hereafter “Analog”) and Dipharma S.A. (“Dipharma”) is pleased to announce that their 20 mg nitisinone abbreviated new drug application (ANDA) has received final approval from the U.S. Food and Drug Administration. Nitisinone Capsules are a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum’s Orfadin®, and are now available in 2, 5, 10 and 20 mg capsules.

Analog currently distributes the 2, 5, and 10 mg products through specialty pharmacies and now has available the 20 mg capsules for distribution.

Nitisinone capsules are a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Since its use as the first-line treatment of HT-1, nitisinone has replaced liver transplantation for this rare condition. The most common side effects of nitisinone are elevated tyrosine levels, low platelet count, low white blood cell count, pink eye, white or cloudy cornea from scarring, inflammation of the cornea, light sensitivity, eye pain, inflammation of the eye lid, cataracts, low granulocytes – cells involved with immunity, nose bleeds, itching of the skin, redness and scaling of the skin, dry skin, rash and hair loss.

Tanya Carro, Executive Vice President, Analog Pharma, commented, “With the approval of the 20 mg capsule, we now have a full complement of room temperature stable strengths for our generic Nitisinone. 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. 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. ”

Analog’s Nitisinone capsules are available to eligible patients for as little as $0* per prescription.

“We are pleased to announce that the FDA has now approved our 20 mg Nitisinone capsules:” – said Marc-Olivier Geinoz, CEO of Dipharma – “For the first time, American HT-1 patients will have access to 20 mg capsules which are stable at room temperature for 3 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 2 to 3 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”.

*Terms and conditions apply