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.
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| 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.

