US-based player Slayback “will kick off a full commercial launch under its own label very soon” of the generic version of Allergan’s Taytulla for which it has just received approval with a competitive generic therapy designation.
Slayback Pharma has championed the US Food and Drug Administration’s competitive generic therapy pathway after receiving approval for an AB-rated generic version of Allergan’s Taytulla (norethindrone acetate/ethinyl capsules; ferrous fumarate capsules) with the CGT designation, “less than eight months from filing.”
Final approval for Slayback’s abbreviated new drug application product, named Merzee, with a CGT designation brings the potential of 180...
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.
