New Product Roundup: Breakthrough, Orphan Status, Fast-Track Designations

The Food and Drug Administration recently granted breakthrough therapy designations to treatments for multiple myeloma, Hodgkin’s lymphoma and non-small cell lung cancer.

The FDA also granted orphan status to products that treat pigmented villonodular synovitis and tenosynovial giant cell tumor, acute myeloid leukemia and for patients at risk of developing myelosuppression following a radiological or nuclear incident.

Additionally, the agency granted fast-track status to a liver cancer drug and qualified infectious disease product (QIDP) designation to an inhaled antibiotic.

Reckitt Benckiser and AntiOp also have entered into an agreement to develop a naloxone nasal spray to treat opioid overdose.

Breakthrough ...