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FDA Watch: Approvals for Amgen, BioMarin; designations for Pfizer, Bluebird Bio

Approvals and designations made by the U.S. Food and Drug Administration for the week ended May 25.

Approvals

* Amgen Inc.'s Prolia, for certain patients with glucocorticoid-induced osteoporosis. The drug is already approved to treat certain postmenopausal women and previously treated patients with osteoporosis.

* BioMarin Pharmaceutical Inc.'s Palynziq, for adults with phenylketonuria. The company plans to launch Palynziq in the U.S. by the end of June.

* Abbott Laboratories' Xience Sierra, a version of its Xience everolimus-eluting coronary stent system.

* Avinger Inc.'s Pantheris lumivascular atherectomy system, for surgeries to treat peripheral artery disease.

* Sun Pharmaceutical Industries Ltd.'s Yonsa, in combination with methylprednisolone, for metastatic castration-resistant prostate cancer. Yonsa is also known as abiraterone acetate, which Johnson & Johnson unit Janssen Research & Development LLC markets as Zytiga.

* Zimmer Biomet Holdings Inc.'s Zyston strut open titanium interbody spacer system, a titanium spinal implant.

* Dova Pharmaceuticals Inc.'s Doptelet, to treat thrombocytopenia in certain adults with chronic liver disease. The company plans to launch Doptelet in June.

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

Complete response letters

* Recro Pharma Inc.'s meloxicam, an intravenous non-opioid painkiller. The FDA said it rejected the drug due to issues with certain data in the application.

Fast track

* Krystal Biotech Inc.'s KB103, for dystrophic epidermolysis bullosa. The FDA previously granted KB103 orphan drug status.

Breakthrough therapy

* Pfizer Inc.'s tafamidis, for transthyretin cardiomyopathy. The FDA previously granted tafamidis orphan drug and fast track designations.

* Bluebird Bio Inc.'s Lenti-D, for cerebral adrenoleukodystrophy, a rare genetic progressive neurodegenerative disease. The FDA previously granted Lenti-D orphan drug and rare pediatric disease designations.