Osaka, Japan – August 15, 2022 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for six generic drugs with 13 strengths. The four compounds marked with an asterisk below are approved for the first time as generics.
The list of approved products
1. Esomeprazole Capsules, Granules for Suspension
| Generic name |
Esomeprazole Magnesium Hydrate* |
| Strengths |
Capsules: 10mg, 20mg
Granules for Suspension: 10mg, 20mg |
| Brand products |
Nexium® Capsules 10mg, 20mg, Nexium® Granules for Suspension 10mg, 20mg |
2. Escitalopram Tablets, OD Tablets
| Generic name |
Escitalopram Oxalate* |
| Strengths |
Tablets: 10mg, 20mg
OD Tablets: 10mg, 20mg |
| Brand products |
Lexapro® Tablets 10mg, 20mg |
3. Ramelteon Tablets
| Generic name |
Ramelteon |
| Strengths |
8mg |
| Brand products |
Rozerem® Tablets 8mg |
4. Tolvaptan OD Tablets
| Generic name |
Tolvaptan |
| Strengths |
7.5mg, 15mg |
| Brand products |
Samsca® OD Tablets 7.5mg, 15mg |
5. Ibandronate Intravenous Injection Syringes
| Generic name |
Ibandronate Sodium Hydrate* |
| Strengths |
1mg |
| Brand products |
Bonviva® Syringes for Intravenous Injection 1mg |
6. Daptomycin for Intravenous Injection
| Generic name |
Daptomycin* |
| Strengths |
350mg |
| Brand products |
Cubicin® IV 350mg |
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.
