Following approval by the FDA, Amneal has launched a generic version of the Butrans buprenorphine transdermal system, immediately initiating commercialization activities across all strengths.
Amneal Pharmaceuticals has launched a generic rival to Purdue’s Butrans (buprenorphine) transdermal system in five strengths in the US, following abbreviated new drug application approval from the US Food and Drug Administration for the product in 5μg/hr, 7.5μg/hr, 10μg/hr, 15μg/hr and 20μg/hr versions.
The company has also been granted competitive generic therapy designation and 180 days of exclusivity for the 7.5μg/hr presentation of...
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.
