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FDA Watch: Approvals for Otonomy, OrbusNeich; rejection for Celgene

Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 2.

Approvals

* Otonomy Inc.'s Otiprio, for patients 6 months and older with external ear canal infection and inflammation caused by bacteria Pseudomonas aeruginosa and Staphylococcus aureus.

* OrbusNeich Medical Company Ltd's 1.0mm Sapphire II PRO coronary balloon, for opening clogged blood vessels.

* Sorrento Therapeutics Inc. and its majority-owned unit Scilex Pharmaceuticals Inc.'s ZTlido, for post-herpetic neuralgia or post-shingles pain. The companies expect to launch the drug in 2018.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Complete response letters

* Celgene Corp.'s ozanimod, for forms of multiple sclerosis that return after treatment. In a refusal-to-file letter, the FDA said the nonclinical and clinical pharmacology sections in Celgene's application were insufficient to conduct a complete review.

Fast track

* FibroGen Inc.'s Pamrevlumab, for locally advanced unresectable pancreatic cancer.

Other designations: orphan drug

* CorMedix Inc.'s taurolidine, for neuroblastoma.