FDA approves Astra Pharmaceutical's ANDA suitability petition for pentamidine isethionate injection, 100 mg/ml in 3 ml vials on Jan. 18. Request was for a change in formulation from the lyophilized powder of Lyphomed's Pentam 300 to a solution. Lyphomed's marketing exclusivity for Pentam expires Oct. 16, 1991.
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US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.