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Controlled-Release AZT Gets FDA Go-Ahead for New Drug Investigation
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 (AZT), marketed
SAN DIEGO--Genta Jago, a joint venture between Genta Incorporatedand Jagotec AG (Hergiswil, Switzerland), has filed an InvestigationalNew Drug application with the FDA for a controlled-release formulationof zidovudine (AZT), marketed by Burroughs Wellcome Co. as Retrovir.
The recommended dosage for AZT in the United States is six timesdaily. Results of pilot in vitro and human pharmacokinetic studiesin Europe suggest that once- or twice-daily dosing may be possiblewith the controlled-release formulation, which incorporates Jagotec'sGeomatrix delivery technology.