Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths

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: 5mg, 10mg, 20mg, DS: 2% Brand products: MEMARY® TABLETS 5mg, 10mg, 20mg, MEMARY® OD TABLETS 5mg, 10mg, 20mg, MEMARY® DRY SYRUP 2% 2. Galantamine Hydrobromide OD Tablets Generic name: Galantamine Hydrobromide* Strengths: 4mg, 8mg, 12mg Brand products: REMINYL® OD Tablets 4mg, 8mg, 12mg 3. Ezetimibe Tablets Generic name: Ezetimibe Strengths: 10mg Brand products: Zetia® Tablets 10mg 4. Dutasteride Capsules Generic name: Dutasteride* Strengths: 0.5mg Brand products: Avolve® Capsules 0.5mg 5. Tadalafil Tablets Generic name: Tadalafil* Strengths: 2.5mg, 5mg Brand products: Zalutia® Tablets 2.5mg, 5mg 6. Repaglinide Tablets Generic name: Repaglinide* Strengths: 0.25mg, 0.5mg Brand products: SUREPOST® Tablets 0.25mg, 0.5mg 7. Imidafenacin Tablets, OD Tablets Generic name: Imidafenacin Strengths: Tablets, OD Tablets: 0.1mg Brand products: URITOS® Tablets 0.1mg, URITOS® OD Tablets 0.1mg, STAYBLA® Tablets 0.1mg, STAYBLA® OD Tablets 0.1mg 8. Levocetirizine Hydrochloride Tablets, OD Tablets, Syrup Generic name: Levocetirizine Hydrochloride* Strengths: Tablets, OD Tablets: 5mg, Syrup: 0.05% Brand products: Xyzal® Tablets 5mg, 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: 100mg, 200mg Brand products: Celecox® Tablets 100mg, 200mg 11. Eldecalcitol Capsules Generic name: Eldecalcitol* Strengths: 0.5μg, 0.75μg Brand products: EDIROL® Capsules 0.5μg, 0.75μg 12. Bazedoxifene Acetate Tablets Generic name: Bazedoxifene Acetate* Strengths: 20mg Brand products: Viviant® Tablets 20mg 13. Rabeprazole Sodium Tablets Generic name: Rabeprazole Sodium Strengths: 5mg Brand products: Pariet® tablets 5mg 14. Blonanserin Powder Generic name: Blonanserin Strengths: 2% Brand products: LONASEN® Powder 2% 15. Deferasirox Granules Generic name: Deferasirox Strengths: 90mg, 360mg Brand products: JADENU® Granules Sachet 90mg, 360mg 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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