The launch of injectable doxercalciferol and FDA approvals for mycophenolic acid delayed-release tablets and betamethasone dipropionate ointment could add some cheer to Lupin whose high-potential launches in the US have seen delays. However, analysts are not very enthused.
Lupin's launch of its generic equivalent to Sanofi's Hectorol (doxercalciferol) injection and US Food and Drug Administration approvals for mycophenolic acid delayed-release tablets and betamethasone dipropionate ointment have added $328m to the company's addressable market size.
With annual sales of around $132m in the US based on IQVIA data to October 2019, doxercalciferol injection 4μg/2ml multi-dose...
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.
