Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths

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 Caplules

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.

 

◆ Contact Information ◆
PR / IR Office, Sawai Pharmaceutical Co., Ltd.
E-mail：koho@sawai.co.jp