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.
