Osaka, Japan – August 15, 2024 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Motohiko Kimura) received approvals by the Ministry of Health, Labour and Welfare for Six generic drugs with 11 strengths. The four compounds marked with an asterisk below are approved for the first time as generics**.
**Ezerosu® Combination Tablets are Ezetimibe and Rosuvastatin Calcium, and are counted as one compound.
The list of approved products
1. Rivaroxaban Tablets, OD Tablets
| Generic name |
Rivaroxaban |
| Strengths |
Tablets, OD Tablets: 10mg, 15mg |
| Brand products |
Xarelto® tablets, OD tablets 10mg, 15mg |
2. Vildagliptin Tablets
| Generic name |
Vildagliptin* |
| Strengths |
Tablets: 50mg |
| Brand products |
Equa® Tablets 50mg |
3. Saxagliptin Tablets
| Generic name |
Saxagliptin Hydrate* |
| Strengths |
Tablets: 2.5mg, 5mg |
| Brand products |
ONGLYZA® Tablets 2.5mg, 5mg |
4. Ezerosu® Combination Tablets
| Generic name |
Ezetimibe, Rosuvastatin Calcium* |
| Strengths |
Combination Tablets: LD, HD |
| Brand products |
ROSUZET® Combination Tablets LD, HD |
5. Hydroxychloroquine Sulfate Tablets
| Generic name |
Hydroxychloroquine Sulfate* |
| Strengths |
Tablets: 200mg |
| Brand products |
Plaquenil® Tablets 200mg |
6. Fingolimod Capsules
| Generic name |
Fingolimod Hydrochloride |
| Strengths |
Capsules: 0.5mg |
| Brand products |
IMUSERA® Capsules 0.5mg, GILENYA® Capsules 0.5mg |
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.
