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Notice to Readers U.S.-Manufactured Pentamidine Isethionate Cleared for Investigational Use

A U.S.-manufactured preparation of pentamidine isethionate has undergone satisfactory completion of chemical and biologic tests, and CDC is now able to include this preparation in its claimed investigational exemption for a new drug for treatment of Pneumocystis carinii pneumonia. The Investigational New Drug status for the U.S.-manufactured preparation makes it unnecessary for CDC to distribute the foreign-produced product (pentamidine methanesulfonate) described in the May 4, 1984, issue of the MMWR (33:225-6). The U.S. preparation is being synthesized by Aldrich Chemical Company, Milwaukee, Wisconsin, and packaged for pharmaceutical use by LyphoMed, Inc., Melrose Park, Illinois.

There are two minor differences between the LyphoMed-manufactured product and the previously used May & Baker preparation of pentamidine isethionate. First, the LyphoMed product contains more pentamidine per vial than the May & Baker product (300 mg, compared with 200 mg). Second, the two preparations differ in their physical appearance. May & Baker uses a "dry fill" manufacturing process that leaves a fluffy white powder in the vial, whereas LyphoMed uses a "wet fill" process, followed by lyophilization, leaving a dry "plug" of white powder at the bottom of the vial.

The dosage of the LyphoMed product is the same as for the May & Baker product (4 mg (salt)/kg body weight). Reported by Div of Parasitic Diseases, Div of Host Factors, Center for Infectious Diseases, CDC.

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