After Lupin’s launch of an authorized generic, Cipla has entered the US market with its own generic rival to Sunovion’s Brovana, after receiving the FDA approval for the inhalation solution. Axar Pharma and Glenmark also currently hold approvals and Teva a tentative approval for arformoterol tartrate abbreviated new drug applications.
Cipla Limited has announced receiving final approval for its generic version of Sunovion’s Brovana (arformoterol tartrate) inhalation solution from the US Food and Drug Administration. The company launched the product immediately in a 15mcg/2ml presentation.
Early this month, Lupin launched an authorized generic rival to Brovana, available as arformoterol tartrate inhalation solution in 15mcg/2ml unit-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.
