FDA's NDA And BLA Approvals
Executive Summary
Original new drugs and biologics recently approved by FDA.
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Crestor Patent Settlement Allows Actavis Generic Entry In May 2016
The agreement permits Actavis to launch its generic version of AstraZeneca’s Crestor 67 days before the patent on the cholesterol-lowering drug expires in return for paying AstraZeneca 39% of its net sales during this period; Actavis may also launch its alternative zinc salt formulation of Crestor at the same time.
Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round
Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.