Genta Sued Over NDA Withdrawal  

Oleh:

Mack, George S.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Nature Biotechnology: The Science and Business of Biotechnology vol. 22 no. 7 (Jul. 2004), page 788.
Topik: withdrawal; genta sued NDA withdrawal

Ketersediaan

Perpustakaan Pusat (Semanggi) Nomor Panggil: NN9.1 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

On May 4, a dark cloud began dumping torrents of class action lawsuits on the new jersey, based bio pharmaceutical firm Genta for allegedly suppressing amterial information regarding both the toxicity and efefctiveness of its antisense drug Genasense for metastatic malignant melanoma. Genta withdrew its new drug application (NDA) for the product on May 13, ten days after the US food and drug administration's (FDA) Oncologic Drug Advisory Committee (ODAC) declined to recommend approval by a vote of 13 - 3.

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