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Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths

Feb. 15. 2021

Osaka, Japan - February 15, 2021 - Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for eight generic drugs with 20 strengths. The five compounds marked with an asterisk below are approved for the first time as generics**.

**Zilmlo® Combination Tablets, OD Tablets are Azilsartan and Amlodipine, and are counted as one compound.

The list of approved products

1. Eszopiclone Tablets

Generic name Eszopiclone*
Strengths 1mg, 2mg, 3mg
Brand products Lunesta® Tablets 1mg, 2mg, 3mg

2. Solifenacin Succinate Tablets, OD Tablets

Generic name Solifenacin Succinate*
Strengths Tablets, OD Tablets: 2.5mg, 5mg
Brand products Vesicare® Tablets 2.5mg, 5mg, Vesicare® OD Tablets 2.5mg, 5mg

3. Zilmlo® Combination Tablets, OD Tablets

Generic name Azilsartan, Amlodipine*
Strengths LD, HD
Brand products ZACRAS® Combination Tablets LD&HD

4. Epinastine Hydrochloride Ophthalmic Solution

Generic name Epinastine Hydrochloride
Strengths 0.05%
Brand products ALESION® Ophthalmic Solution 0.05%

5. Duloxetine Capsules

Generic name Duloxetine Hydrochloride*
Strengths 20mg, 30mg
Brand products Cymbalta® Capsules 20mg, 30mg

6. Tadalafil Tablets AD

Generic name Tadalafil
Strengths 20mg
Brand products Adcirca® Tablets 20mg

7. Pemetrexed for Intravenous Infusion, Intravenous Infusion

Generic name Pemetrexed
Strengths For Intravenous Infusion 800mg,
Intravenous Infusion 100mg, 500mg, 800mg
Brand products Alimta® Injection 100mg, 500mg

8. Palonosetron Intravenous Infusion Bags

Generic name Palonosetron Hydrochloride*
Strengths 0.75mg/100mL
Brand products Aloxi® I.V. Infusion Bag 0.75mg

 

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