Osaka, Japan – February 17, 2020 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths. The 10 compounds marked with an asterisk below are approved for the first time as generics**.
**PusoFeki Combination Tablets are Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride, and are counted as one compound.
The list of approved products:
1. Memantine Hydrochloride Tablets, OD Tablets, Dry Syrup
| Generic name |
Memantine Hydrochloride* |
| Strengths |
Tablets, OD Tablets: 5 mg, 10 mg, 20 mg,
DS: 2% |
| Brand products |
MEMARY® TABLETS 5 mg, 10 mg, 20 mg, MEMARY® OD TABLETS 5 mg, 10 mg, 20 mg,
MEMARY® DRY SYRUP 2% |
2. Galantamine Hydrobromide OD Tablets
| Generic name |
Galantamine Hydrobromide* |
| Strengths |
4 mg, 8 mg, 12 mg |
| Brand products |
REMINYL® OD Tablets 4 mg, 8 mg, 12 mg |
3. Ezetimibe Tablets
| Generic name |
Ezetimibe |
| Strengths |
10 mg |
| Brand products |
Zetia® Tablets 10 mg |
4. Dutasteride Capsules
| Generic name |
Dutasteride* |
| Strengths |
0.5 mg |
| Brand products |
Avolve® Capsules 0.5 mg |
5. Tadalafil Tablets
| Generic name |
Tadalafil* |
| Strengths |
2.5 mg, 5 mg |
| Brand products |
Zalutia® Tablets 2.5 mg, 5 mg |
6. Repaglinide Tablets
| Generic name |
Repaglinide* |
| Strengths |
0.25 mg, 0.5 mg |
| Brand products |
SUREPOST® Tablets 0.25 mg, 0.5 mg |
7. Imidafenacin Tablets, OD Tablets
| Generic name |
Imidafenacin |
| Strengths |
Tablets, OD Tablets: 0.1 mg |
| Brand products |
URITOS® Tablets 0.1 mg, URITOS® OD Tablets 0.1 mg,
STAYBLA® Tablets 0.1 mg, STAYBLA® OD Tablets 0.1 mg |
8. Levocetirizine Hydrochloride Tablets, OD Tablets, Syrup
| Generic name |
Levocetirizine Hydrochloride* |
| Strengths |
Tablets, OD Tablets: 5 mg, Syrup: 0.05% |
| Brand products |
Xyzal® Tablets 5 mg, Xyzal® Syrup 0.05% |
9. PusoFeki Combination Tablets
| Generic name |
Fexofenadine Hydrochloride, Pseudoephedrine Hydrochloride* |
| Brand products |
dellegra® Combination Tablets |
10. Celecoxib Tablets
| Generic name |
Celecoxib* |
| Strengths |
100 mg, 200 mg |
| Brand products |
Celecox® Tablets 100 mg, 200 mg |
11. Eldecalcitol Capsules
| Generic name |
Eldecalcitol* |
| Strengths |
0.5 μg, 0.75 μg |
| Brand products |
EDIROL® Capsules 0.5 μg, 0.75 μg |
12. Bazedoxifene Acetate Tablets
| Generic name |
Bazedoxifene Acetate* |
| Strengths |
20 mg |
| Brand products |
Viviant® Tablets 20 mg |
13. Rabeprazole Sodium Tablets
| Generic name |
Rabeprazole Sodium |
| Strengths |
5 mg |
| Brand products |
Pariet® tablets 5 mg |
14. Blonanserin Powder
| Generic name |
Blonanserin |
| Strengths |
2% |
| Brand products |
LONASEN® Powder 2% |
15. Deferasirox Granules
| Generic name |
Deferasirox |
| Strengths |
90 mg, 360 mg |
| Brand products |
JADENU® Granules Sachet 90 mg, 360 mg |
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.
