Monday, March 25, 2013

Daiichi Sankyo Receives Approval in Japan for Manufacture and Marketing of PRALIA ® and approval for Additional Indication of Anticancer Agent Topotecin(R) Intravenous Drip Infusion

Daiichi Sankyo has received two new approvals from MHLW today
1)It received approval for a supplemental new drug application (sNDA) for an additional indication for Topotecin® intravenous drip infusion 40 mg and 100 mg (irinotecan hydrochloride hydrate) for pediatric malignant solid tumor to Japan’s Ministry of Health, Labor and Welfare. 

2)Approval to  manufacture and market the osteoporosis treatment PRALIA ®subcutaneous injection 60mg syringe (INN: Denosumab; genetic recombination) for the treatment of osteoporosis.

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