Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 8.
Approvals
* Johnson & Johnson's Spravato, an esketamine nasal spray for treatment-resistant depression. The medicine — derived from ketamine, a known club drug — will be offered through a restricted distribution system due to its potential for abuse.
* Roche Holding AG's combination of Tecentriq and Celgene Corp.'s chemotherapy drug Abraxane for triple-negative breast cancer patients, whose disease has worsened or has spread to other parts of the body and expresses PD-L1.
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| FDA headquarters in Silver Spring, Md. |
| Source: Associated Press |
Priority review
* Regeneron Pharmaceuticals Inc. and Sanofi's Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps.
* Eli Lilly and Co.'s Emgality to prevent episodic cluster headaches in adults. Emgality was previously approved to prevent migraine in adults.
* Celgene Corp.'s fedratinib for myelofibrosis.
Other designations
* Orphan drug, for Celgene's fedratinib, for secondary and primary myelofibrosis.
* Orphan drug, for Acceleron Pharma Inc.'s ACE-083, for Charcot-Marie-Tooth disease.
* Rare pediatric disease, for Inventiva SA's odiparcil, for mucopolysaccharidosis VI, also known as Maroteaux-Lamy syndrome.