Endo Announces Approval of First Generic Orfadin® in U.S.
Endo International plc - Ordinary Shares (ENDP)
Last endo international plc - ordinary shares earnings: 2/26 06:00 am
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Source: PR Newswire
DUBLIN, Sept. 4, 2019 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that Novitium Pharma, LLC, a partner of Endo's subsidiary Endo Ventures Limited, received approval from the U.S. Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin® (nitisinone capsules). Endo's operating company Par Pharmaceutical, Inc. expects to distribute the product through specialty pharmacies beginning this month. Nitisinone capsules are 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."We are pleased to offer this rare patient population suffering from HT-1 the first and only bioequivalent and therapeutically equivalent option to Orfadin® capsules. Additionally, the product can be stored at room temperature which is an added convenience to patients," said Domenic Ciarico, Executive Vice Pre
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