Endo Announces Approval of First Generic Orfadin® in U.S.
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 President and Chief Commercial Officer, Sterile and Generics. "We are proud to continue our tradition at Par of providing high quality, affordable medicines to patients."
"Novitium has a history of impressive development and execution skills and we are pleased to have several products under development with them," said
According to Swedish Orphan Biovitrum, global sales for Orfadin® were approximately
Hereditary Tyrosinemia type-1 (HT-1) is a rare and serious inherited metabolic disease caused by the inability to metabolise the amino acid tyrosine. Left untreated, HT-1 can cause hepatic, renal and peripheral nerve damage. HT-1 affects at least 1 in 100,000 patients worldwide, with approximately 150 patients in
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This press release may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including the statements from Messrs. Ciarico and Rockwell and other statements regarding research and development outcomes, regulatory, marketing and reimbursement approvals, efficacy, adverse reactions, market and product potential and product availability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with the