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BDR Pharmaceuticals sues FDA over VOQUEZNA exclusivity, challenging NCE protection
PHATPhathom Pharmaceuticals, Inc.
BDR Pharmaceuticals International Pvt. Ltd. filed suit against the U.S. Food and Drug Administration in the United States District Court for the District of Columbia, challenging the agency's refusal to receive an abbreviated new drug application referencing Phathom’s VOQUEZNA. BDR alleges that FDA improperly applied the GAIN Act to extend Phathom’s New Chemical Entity exclusivity through May 3, 2032. Phathom believes the FDA correctly evaluated the issue and intends to take action to protect its statutory exclusivities. The company operates in the pharmaceutical industry.