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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.