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Sawai Receives Approvals for Four Generic Drugs with Eight Strengths

Aug. 16. 2021

Osaka, Japan - August 16, 2021 - Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for four generic drugs with eight strengths. The three compounds marked with an asterisk below are approved for the first time as generics.

The list of approved products

1. Levetiracetam Tablets, Granular tablets, Dry syrup

Generic name Levetiracetam*
Strengths Tablets: 250 mg, 500 mg,
Granular tablets: 250 mg, 500 mg, DS: 50%
Brand products E Keppra® Tablets 250 mg, 500 mg, E Keppra® Dry syrup 50%

2. Ambrisentan Tablets

Generic name Ambrisentan*
Strengths 2.5 mg
Brand products Volibris Tablets 2.5 mg

3. Olopatadine Ophthalmic Solution

Generic name Olopatadine
Strengths 0.1%
Brand products Patanol® Ophthalmic Solution 0.1%

4. Iguratimod Tablets

Generic name Iguratimod*
Strengths 25 mg
Brand products Careram® Tablets 25 mg

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