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Drugs nnmunended for approval inJapan

Nine drugs were recently recommended for approval by the executive committee of the Japanese Central Pharmaceutical Affairs Council, 3 of which were worldwide new chemical entities (NCEs) [Scrip 1965: 24, 11 Oct 1994).

These worldwide NCEs were the oral cardiostimulant docarpamine, the insulin-like growth factor I (somatomedin C) mecasermin and the low molecular weight heparin pamaparin. These compounds, as well as the other recommended products, are listed in the table below.

18b1e: ~ reoommeoded for approval in Japan

Generic drug Product Coml*\Y Indlcalon NIftIe brWIdrwme

Oocarpamlne Tanadopae Tanabe Diuretic

Mecasermln Somazone Fujlsawa Insulin-resistant diabetes melUtus andgrowlh hofmone-reslstant dwatfism

Pamaparin l.ohepae Shimizu Low molecular weight hepaJ1n lor ciatysis

Indomethacin Indacine Banyu(Merck Treatment-resistant & Co.) circutatory

disorders In premature neonates

Human Mitsubishl Kasel D\aglosis 01 c:orticorelln honnone functions

Porfirner sodium photofrlne Ledette Early·stage cancers

Terguride Terulone ScheringAG Hyperprolactinaem~

Pinnenol Plm~ Wamer- ArrIty1hmla Lambert

Mesna Urornitexane Shionogj ifosfamide-assoc-Iated urogenital adVerse effects

22 Oct 1994INPHARMA- 0156·2703'9410960·000221$01 .00° Adl. Internetlonel Limited 1994. All right. r_rved