Eagle Pharmaceutics Inc. said Wednesday it has won Food and Drug Administration Qualified Infectious Disease Product (QDIP) and Fast-Track Designation for...
Eagle Pharmaceutics Inc.
said Wednesday it has won Food and Drug Administration Qualified Infectious Disease Product and Fast-Track Designation for CAL02, a treatment for severe community-acquired bacterial pneumonia as an add-on therapy to standard of care. The former designation will entitle the company to an additional eight to 10 years of regulatory exclusivity if the product is approved. Eagle also believes CAL02 is a new chemical entity, which would result in five years of marketing exclusivity.
said Wednesday it has won Food and Drug Administration Qualified Infectious Disease Product and Fast-Track Designation for CAL02, a treatment for severe community-acquired bacterial pneumonia as an add-on therapy to standard of care. The former designation will entitle the company to an additional eight to 10 years of regulatory exclusivity if the product is approved. Eagle also believes CAL02 is a new chemical entity, which would result in five years of marketing exclusivity.
Malaysia Latest News, Malaysia Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Watch: Nick Taylor sinks eagle putt to win Canadian Open, first Canadian winner since 1954TORONTO — Nick Taylor became the first Canadian in 69 years to win his national open, holing a 72-foot eagle putt on the fourth playoff hole to beat Tommy...
Read more »
Patio restaurant Smoky Rose to expand to new Dallas spot: former Dallas EaglePatio restaurant Smoky Rose to expand to new Dallas spot: former Dallas Eagle gay bar
Read more »
Driver in fatal Eagle Mountain road rage crash charged with manslaughterA man who police say killed two people in a road rage-related crash in Eagle Mountain was charged Tuesday with manslaughter.
Read more »
Hiker describes encounter with sow, cubs along South Fork Eagle River Trail“In that split-second where I turned and I saw her, I didn’t think I was going to come out of it. My initial instinct was, ‘This is it,'' the hiker said.
Read more »
Golfer Adam Hadwin mistakenly leveled by security when celebrating Nick Taylor's fairytale Canadian Open win | CNNA security guard, appearing to mistake Hadwin for an invading member of the gallery, skirted around Taylor to take down the bottle-wielding golfer, driving him to the floor of the 18th green with a tackle.
Read more »