Oncology NEWS International. Vol. 4 No. 4

Controlled-Release AZT Gets FDA Go-Ahead for New Drug Investigation

April 1, 1995

SAN DIEGO--Genta Jago, a joint venture between Genta Incorporated and Jagotec AG (Hergiswil, Switzerland), has filed an Investigational New Drug application with the FDA for a controlled-release formulation of zidovudine(Drug information on zidovudine) (AZT), marketed by Burroughs Wellcome Co. as Retrovir.

The recommended dosage for AZT in the United States is six times daily. Results of pilot in vitro and human pharmacokinetic studies in Europe suggest that once- or twice-daily dosing may be possible with the controlled-release formulation, which incorporates Jagotec's Geomatrix delivery technology.

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Controlled-Release AZT Gets FDA Go-Ahead for New Drug Investigation

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