Osaka, Japan - February 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 seven generic drugs with 14 strengths. The five compounds marked with an asterisk below are approved for the first time as generics.
The list of approved products
1. Tolvaptan Granules
| Generic name |
Tolvaptan* |
| Strengths |
Granules: 1% |
| Brand products |
Samsca® granules 1% |
2. Febuxostat Tablets, OD Tablets
| Generic name |
Febuxostat* |
| Strengths |
Tablets: 10 mg, 20 mg, 40 mg
OD Tablets: 10 mg, 20 mg, 40 mg |
| Brand products |
Feburic® Tablets 10 mg, 20 mg, 40 mg |
3. Teriparatide Injection
| Generic name |
Teriparatide Acetate |
| Strengths |
Injection: 56.5 μg |
| Brand products |
Teribone® Injection 56.5 μg |
4. Dasatinib Tablets
| Generic name |
Dasatinib Hydrate* |
| Strengths |
Tablets: 20 mg, 50 mg |
| Brand products |
SPRYCEL® Tablets 20 mg, 50 mg |
5. Azacitidine for Injection
| Generic name |
Azacitidine* |
| Strengths |
Injection: 100 mg |
| Brand products |
Vidaza® for Injection 100 mg |
6. Aripiprazole Tablets, Oral Solution
| Generic name |
Aripiprazole |
| Strengths |
Tablets: 1 mg
Oral Solution: 1 mg |
| Brand products |
ABILIFY® tablets 1 mg, ABILIFY® oral solution 0.1% |
7. Omega-3-Acid Ethyl Esters Granular Capsules
| Generic name |
Omega-3-acid ethyl esters* |
| Strengths |
Granular Capsules: 2 g |
| Brand products |
LOTRIGA® 2 g |
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.
