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FDA Watch: Approvals for J&J, Roche; designations for Regeneron, Sanofi

Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 8.


* 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.

SNL Image
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.