MHLW Approves New Indication for DONEPEZIL Tablets, OD Tablets and Fine Granules
Osaka, Japan – March 27, 2019 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change applications by the Ministry of Health, Labour and Welfare (MHLW) for DONEPEZIL HYDROCHLORIDE Tablets 3 mg, 5 mg and 10 mg [SAWAI], DONEPEZIL HYDROCHLORIDE OD Tablets 3 mg, 5 mg and 10 mg [SAWAI], and DONEPEZIL HYDROCHLORIDE Fine Granules 0.5 % [SAWAI]*.
This approval expands the indication of DONEPEZIL HYDROCHLORIDE products to include the same uses as their brand equivalents.
* Brand products: Aricept® Tablets 3 mg, 5 mg and 10 mg, Aricept® D Tablets 3 mg, 5 mg and 10 mg, Aricept® Fine Granules 0.5 %
“Indications and Usage” and “Dosage and Administration” after approvals are described below (New approval is underlined);
Indications and Usage
- Suppression of progression of dementia symptoms in dementia of the Alzheimer’stype
- Suppression of progression of dementia symptoms in dementia with Lewybodies
Dosage and Administration
- Suppression of progression of dementia symptoms in dementia of the Alzheimer’stype
The usual initial adult dose for oral use is 3 mg of donepezil hydrochloride once daily. After 1 to 2 weeks the dose is increased to 5 mg. The dosage for patients with severe dementia of the Alzheimer’s type is increased to 10 mg after dosing at 5 mg for 4 or more weeks. The dose can be reduced appropriately according to patients’ symptoms.
- Suppression of progression of dementia symptoms in dementia with Lewybodies
The usual initial adult dose for oral use is 3 mg of donepezil hydrochloride once daily. After 1 to 2 weeks the dose is increased to 5 mg. The dose is increased to 10 mg after dosing at 5 mg for 4 or more weeks. The dose can be reduced to 5 mg according to patients’ symptoms.
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.
About Sawai
Founded in 1929, Sawai Pharmaceutical Co., Ltd. has grown into one of the leading generics companies in Japan. Guided by its corporate philosophy, “Always Putting Patients First,” Sawai markets more than 310 high-quality generic drugs with 760 strengths and reliably delivers them to patients throughout Japan. In 2017, Sawai acquired US-based Upsher-Smith Laboratories, LLC marking its first step in overseas expansion to become a globally recognized generic pharmaceutical company. For more information, visit: https://www.sawai.co.jp/en/.
For further information please contact:
PR/IR group, koho@sawai.co.jp