Saturday, May 30 2020, 11:13 am
Clinical Pharmacology and Biopharmaceutics Review(s)

Clinical Pharmacology and Biopharmaceutics Review(s)

The Office of Clinical Pharmacology Division of Clinical Pharmacology IV has reviewed the information contained in NDA 210913. The clinical pharmacology information supports the use of OTX-101 0.09% in patients with KCS [see Table 1.1.1] and the clinical pharmacology review team recommends approval of this NDA. Table 1.1.1.