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The submitted data did not rule out the possibility the proposed formulation could result in more abuse via injection than using a conventional oxycodone formulation. Read More
The FDA declined to approve a Pharmaceutical Manufacturing Research Services NDA for a new oxycodone hydrochloride product due to insufficient evidence of its abuse-deterrent properties, the agency said a Feb. 12 notice. Read More
The FDA issued a complete response letter to Aradigm over its Linhaliq (ciprofloxacin liposomal) submission for non-cystic fibrosis bronchiectasis, a severe, rare lung disease frequently associated with chronic lung infections, saying the drug could not be approved in its current form. Read More
The approval was based on two clinical studies with statistically significant reductions in treated bleeds compared to previous treatments with a bypassing agent. Read More