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 |