Years after introducing the first US generic version of Advair, Viatris is leading the way on another respiratory launch with Breyna, the first US rival to Symbicort.
Having several years ago broken new ground in the US generics market by launching the first approved rival to Advair (fluticasone/salmeterol) in early 2019, Viatris is once again leading the way on a respiratory complex generic by introducing its Breyna (budesonide/formoterol) version of AstraZeneca’s Symbicort brand.
Launched in collaboration with Kindeva Drug Delivery, Breyna will be “immediately available” in both 80mcg/4.5mcg and 160mcg/4.5mcg strengths, Viatris announced.
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.
