By being able to be stored at room temperature, Par’s first generic of Sobi’s Orfadin nitisinone capsules offer a competitive advantage over the reference brand.
Endo’s Par Pharmaceutical operating unit expects this month to start distributing through specialty pharmacies the first US generic alternative to Sobi’s Orfadin (nitisinone) 2mg, 5mg and 10mg capsules for treating adults and children with hereditary tyrosinemia type-1 (HT-1), a genetic disorder characterized by elevated blood levels of the amino acid tyrosine.
Citing data from Sobi, Endo said global sales of Orfadin were around $85m over the past four quarters. The Swedish...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
