Phathom Pharmaceuticals Submits Citizen Petition to FDA Seeking Correction of Orange Book Listings for VOQUEZNA® (vonoprazan) Tablets
Orange(ORAN) GlobeNewswire News Room·2024-12-11 13:00
Citizen Petition seeks correction of expiration date for New Chemical Entity (NCE) exclusivity on VOQUEZNA (vonoprazan) tablets Orange Book listingsPhathom believes applicable law mandates a 10-year NCE exclusivity period (from date of first approval of drug containing vonoprazan) benefitting all vonoprazan-based products, with exclusivity until May 3, 2032 FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing an ...