Sawai Receives Approvals for Three Generic Drugs with Six Strengths

Feb. 15. 2019

Osaka, Japan – February 15, 2019 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for three compounds with six strengths of generic drugs. Among the three compounds, one compound, Blonanserin is approved for the first time as a generic.

The list of approved products:

1. Silodosin OD Tablets 2 mg [SAWAI] and 4 mg [SAWAI]

Generic name Silodosin
Indications Bladder outlet obstruction associated with prostatic hyperplasia
Brand products URIEF® OD Tablets 2 mg and 4 mg, and URIEF® Tablets 2 mg and 4 mg

2. Gefitinib Tablets 250 mg [SAWAI]

Generic name Gefitinib
Indications Inoperable or recurrent non-small cell lung cancer with mutated EGFR
Brand products IRESSA® Tablets 250

3. Blonanserin Tablets 2 mg [SAWAI], 4 mg [SAWAI] and 8 mg [SAWAI]

Generic name Blonanserin
Indications Schizophrenia
Brand products Lonasen® Tablets 2 mg, 4 mg and 8 mg, and Lonasen® Powder 2%

The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.