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Catalyst Pharmaceuticals, Inc.’s and KYE Pharmaceuticals’ Lawsuit in Canadian Federal Court Quashes the Notice of Compliance (NOC) for Ruzurgi®
June 03, 2021 13:20 ET | Source: Catalyst Pharmaceuticals, Inc. Catalyst Pharmaceuticals, Inc.
- Without an NOC, Ruzurgi is without a Marketing Authorization in Canada
- Matter Remanded Back to Health Canada to Provide a More Transparent Record of Its Decision in Light of Firdapse
®
’s Data Protection
CORAL GABLES, Fla., June 03, 2021 (GLOBE NEWSWIRE) Catalyst Pharmaceuticals, Inc. ( Catalyst ) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing and commercializing novel high-quality medicines for patients living with rare diseases, and KYE Pharmaceuticals Inc. ( KYE ), a private company headquartered in Mississauga, Ontario and focused on bringing medicines that fulfill clinically significant unmet needs to the Canadian market, to
Tetra Bio-Pharma: Health Canada Accepts New Drug Submission for REDUVO as a Treatment for Patients with Chemotherapy-induced Nausea and Vomiting
The Company approaches a significant milestone advancing from a pre-revenue biotech to in revenue
OTTAWA, ON / ACCESSWIRE / June 2, 2021 /
Tetra Bio-Pharma
Inc. ( Tetra or the Company ) (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development announced today that Health Canada has accepted its New Drug Submission (NDS) for REDUVO and has formally entered the final review phase in the drug review process. If successful, REDUVO will be issued a Notice of Compliance (NOC) as well as a Drug Identification Number (DIN) which permits Tetra to market the drug in Canada and indicates the drug s official approval in Canada.