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Sawai Pharmaceutical receives approvals for 8 compounds with 19 strengths of generic drugs

Feb. 15. 2018

Osaka, Japan – February 15, 2018 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approvals by the Ministry of Health, Labour and Welfare for 8 compounds with 19 strengths of generic drugs. Among 8 compounds, 6 compounds, Irubesarutan / Amlodopine, Minodronic Acid Hydrate, Lamotrigine, Nalfurafine Hydrochloride, Lanthanum Carbonate and Oseltamivir Phosphate, are approved for the first time as generics.

* ILUAMIX® Combination Tablets LD / HD are Irbesartan and Amlodipine Besilate, and are counted as 1 compounds.

Products received approvals are as below;

Therapeutic Category Product Name Name of Originator drug
Long-acting ARB / Long-acting Ca antagonists ILUAMIX® Combination Tablets LD [SAWAI]
ILUAMIX® Combination Tablets HD [SAWAI]
AIMIX®
Selective histamine H1receptor antagonists / Allergic disease treatment BEPOTASTINE BESILATE OD Tablets 5 mg [SAWAI]
BEPOTASTINE BESILATE OD Tablets 10 mg [SAWAI]
BEPOTASTINE BESILATE Tablets 5 mg [SAWAI]
BEPOTASTINE BESILATE Tablets 10 mg [SAWAI]
TALION® OD Tablets 5 mg
TALION® OD Tablets 10 mg
TALION® Tablets 5 mg
TALION® Tablets 10 mg
Osteoporosis treatment agents MINODRONIC ACID Tablets 1 mg [SAWAI]
MINODRONIC ACID Tablets 50 mg [SAWAI]
Bonoteo® Tablets 1 mg
Bonoteo® Tablets 50 mg
RECALBON® Tablets 1 mg
Antiepileptic therapeutic agents / Bipolar disorder treatment LAMOTRIGINE Tablets 25 mg [SAWAI]
LAMOTRIGINE Tablets 100 mg [SAWAI]
Lamictal® Tablets 25 mg
Lamictal® Tablets 100 mg
Antiepileptic therapeutic agents LAMOTRIGINE Tablets 2 mg for Pediatric [SAWAI]
LAMOTRIGINE Tablets 5 mg for Pediatric [SAWAI]
Lamictal® Tablets 2 mg
Lamictal® Tablets 5 mg
Oral pruritus improving agents NALFURAFINE HYDROCHLORIDE OD Tablets 2.5 μg [SAWAI] REMITCH® OD TABLETS 2.5 μg
REMITCH® capsules 2.5 μg
NOPICOR® capsules 2.5 μg
Hyperphosphatemia treatment agents LANTHANUM CARBONATE Granules 250 mg [SAWAI]
LANTHANUM CARBONATE Granules 500 mg [SAWAI]
Fosrenol® Granules 250 mg
Fosrenol® Granules 500 mg
Anti-influenza virus agents OSELTAMIVIR Capsules 75 mg [SAWAI]
OSELTAMIVIR DS 3% [SAWAI]
TAMIFLU® Capsule 75
TAMIFLU® Dry Syrup 3%
New quinolone antibacterial agent for injectable LEVOFLOXACIN IV Drip Infusion Bag 500 mg / 100 mL [SAWAI]
LEVOFLOXACIN IV Drip Infusion 500 mg / 20 mL [SAWAI]
CRAVIT® INTRAVENOUS DRIP INFUSION BAG 500 mg / 100mL
CRAVIT® INTRAVENOUS DRIP INFUSION 500 mg / 20ml