Sawai Receives Approvals for Seven Generic Drugs with 14 Strengths

Feb. 15. 2022

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.