Hospira Japan Receives Approval of Additional Dosage/Administration for "Paclitaxel I.V. infusion [Hospira]"

On September 27, 2015 Hospira Japan Co., Ltd. reported that the company has received an approval for the additional dosage/administration of gastric cancer for "Paclitaxel I.V. infusion [Hospira]" by a new drug application (NDA) based on evidence in the public domain with the Ministry of Health, Labour and Welfare (MHLW) in Japan (Press release, Hospira, SEP 27, 2015, View Source;p=RssLanding&cat=news&id=2090640 [SID:1234507569]).

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[Product name]
1. Paclitaxel I.V. lnfusion 30mg/5mL [Hospira]
2. Paclitaxel I.V. lnfusion 100mg/16.7mL [Hospira]

[Therapeutic Category]
Anticancer drug

[Dosage /administration for gastric cancer]
The underlined text represents the additional dosage/administration.

Method A or E are used for gastric cancer.
Method A: Normally for adults 210 mg/m2 (body surface area) in terms of Paclitaxel is administered over 3 hours in a single infusion, with intervals of at least three weeks between doses. This forms one course, which is repeated.
Method E: Normally for adults 80 mg/m2 (body surface area) in terms of paclitaxel is administered over 1 hour in a single infusion, once per week for three successive weeks, followed by an interval of at least two weeks. This forms one course, which is repeated.
Doses may be suitably reduced having regard to the condition of the patient.

On the basis of the requirement of the additional dosage/administration for gastric cancer for originator, which includes Paclitaxel, the report was prepared by the "Review Committee on Unapproved Drugs and Indications with High Medical Needs." The decision was made based on the report at the meeting of the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sedation Council, held on March 5, 2015, which confirmed that filing through the "NDA based on evidence in the public domain" was reasonable for this additional dosage/administration.

The MHLW notification related to "NDA based on evidence in the public domain" for generics recommends pharmaceutical companies work on filing for additional dosage/administration for generic at the same time as originators. Hospira Japan filed this additional dosage/administration for "Paclitaxel I.V. infusion 30mg/5mL [Hospira] " and "Paclitaxel I.V. infusion 100mg/16.7mL [Hospira] " by "NDA based on evidence in the public domain."

Hospira Japan is committed to contributing to healthcare in Japan by providing value-added products with its broad portfolio and meeting the expectations of patients and healthcare professionals.