Santen Oy Receives Marketing Authorization for its Glaucoma and Ocular Hypertension Treatment, TAFLOTAN™ in Denmark
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May 7, 2008 Osaka Japan-- Santen Pharmaceutical Co., Ltd. announced that Santen Oy, a wholly owned subsidiary in Finland, Tampere, has received the marketing authorization for its new glaucoma and ocular hypertension treatment drug TAFLOTAN (development code: DE-085, generic name: Tafluprost) in Denmark on April 30, 2008.
TAFLOTAN is a prostaglandin analogue developed for reduction of intraocular pressure in primary open angle glaucoma and ocular hypertension, which was co-developed by Santen Pharmaceutical Co., Ltd. and Asahi Glass Co., Ltd. Santen conducted pharmaceutical and clinical development, while Asahi Glass is responsible for manufacturing development of the active pharmaceutical ingredient.
Santen Oy submitted the marketing authorization application (MAA) in Europe on April 2, 2007, and the scientific review was completed on March 19, 2008 by Germany---the reference member state. Santen Oy received an approved recommendation of the marketing authorization for TAFLOTAN. After approval procedure was completed in each country, the first national approval was granted in Denmark. The approval for the remaining countries will be granted within 1 year, and an update will be provided with the quarterly report.
Glaucoma causes damage to the optic nerve, resulting in major visual defects, such as blindness or visual loss. Speculating that there are many untreated patients, early detection and early treatment of glaucoma is an important issue. Santen expects TAFLOTAN will offer a new treatment option for glaucoma patients, leading to improved quality of life.
Santen Pharmaceuticals filed for Manufacturing and Marketing Approval for Tafluprost to the Japanese Ministry of Health, Labor and Welfare on July 31, 2006.
About Tafluprost
| Development code: |
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DE-085 (generic name: Tafluprost) |
| Dosage form: |
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Aqueous ophthalmic solution |
| Indication: |
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Glaucoma and ocular hypertension |
| Dosage: |
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1 drop/time, once daily |
| Storage method: |
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Can be stored at room temperature |
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