After receiving FDA approval for its generic aminocaproic acid with 180 days of exclusivity under the agency’s Competitive Generic Therapy pathway, Amneal has launched the rival to Amicar. At the same time, it has also begun selling a generic version of Revatio and has also claimed the first generic rival to Carafate.
Amneal has launched generic aminocaproic acid 500mg tablets with 180 days of exclusivity in the US, after receiving US Food and Drug Administration approval for the rival to Amicar which had previously been granted a Competitive Generic Therapy designation by the agency.
Guidance on the CGT pathway was published by the FDA earlier this year “to encourage generic entry for drugs that...
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.
