Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto City, Nagano, Japan; President and CEO: Mutsuo Kanzawa; “Kissei”) announced today that it has received approval in Japan for a supplemental New Drug Application (NDA) of a respiratory stimulant DOPRAM® Injectable 400mg (generic name: doxapram hydrochloride hydrate, Japanese Pharmacopoeia) for an additional indication and dosage and administration of an apneic attack of prematurity after submitｔing an application with public knowledge.
Kissei had received an urgent request from healthcare professionals to develop an additional indication of the drug to treat apneic attacks of prematurity, and submitted the supplemental NDA for an additional indication of DOPRAM® in May 2014.
Kissei expects this approval to provide a new treatment option for patients and healthcare professionals.
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Indication, Dosage and Administration (about apneic attack of prematurity)
| Indication | Primary apnea in premature and low-birth-weight infants (apneic attack of prematurity), only when the desired effect is not obtained on treatment with xanthine preparations. |
| Dosage and Administration | Primary apnea in premature and low-birth-weight infants (apneic attack of prematurity): Usually, doxapram (1.5 mg/kg) is administered as an intravenous infusion over 1 h |
| 1. | Approval of an Additional Indication of ... 2009/02/24 |