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MPR Drug News

Priority Review Granted For New Orkambi Indication

Vertex has announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to their supplemental New Drug Application (sNDA) for Orkambi (lumacaftor/ivacaftor).

FDA Grants Fast Track Designation for Melioidosis Treatment

Soligenix announced that the Food and Drug Administration (FDA) has granted Fast Track designation to SGX943 (dusquetide), a proposed adjunctive therapy for the treatment of melioidosis, a potentially fatal infection.

Antipsychotic Use in Youth With Autism, Intellectual Disability Analyzed

Data from a study published in the Journal of the American Academy of Child and Adolescent Psychiatry suggest that among youths treated with antipsychotics, the number of adolescents diagnosed with autism or intellectual disability has increased, and that more youths with autism or intellectual disability have received antipsychotics.

Nuplazid Launched for Parkinson's Disease Psychosis

Acadia announced the launch of Nuplazid (pimavanserin) tablets for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

New Combo Drug for Type 2 Diabetes Approved

The Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin, metformin HCl extended-release; Boehringer Ingelheim and Lilly) tablets as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin are approrpriate.