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Sawai Receives Approvals for Five Generic Drugs with 11 Strengths

Aug. 18. 2025

Osaka, Japan – August 15, 2025 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Motohiko Kimura) received approvals by the Ministry of Health, Labour and Welfare for Five generic drugs with 11 strengths. The three compounds marked with an asterisk below are approved for the first time as generics.

The list of approved products

1. DAPAGLIFLOZIN Tablets, OD Tablets

Generic name Dapagliflozin*
Strengths Tablets: 5mg, 10mg
OD Tablets: 5mg, 10mg
Brand products forxiga tablets 5mg, 10mg

2. LACOSAMIDE Tablets, DS

Generic name Lacosamide*
Strengths Tablets: 50mg, 100mg
DS: 10%
Brand products VIMPAT® TABLETS 50mg, 100mg
VIMPAT® DRY SYRUP 10%

3. EFINACONAZOLE Solution

Generic name Efinaconazole
Strengths Solution: 10%
Brand products CLENAFIN® Topical Solution 10%

4. NILOTINIB Capsules

Generic name Nilotinib*
Strengths Capsules: 150mg, 200mg
Brand products Tasigna® Capsules 150mg, 200mg

5. ABIRATERONE ACETATE Tablets

Generic name Abiraterone Acetate
Strengths Tablets: 250mg
Brand products ZYTIGA® tablets 250mg

The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.

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