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.