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Newron Pharmaceuticals S.p.A.: Newron Announces Paragraph IV ANDA Filings for Xadago (safinamide) in the USA


Newron Pharmaceuticals S.p.A.: Newron Announces Paragraph IV ANDA Filings for Xadago (safinamide) in the USA
Newron Pharmaceuticals S.p.A. ( Newron ) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that with reference to its media release of May 4, 2021, it received further Paragraph IV Notice Letters regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents. Such further Paragraph IV Notice Letters are not unusual and additional similar notices from other generic manufacturers may follow. ....

Kyongsang Bukto , South Korea , United States , United Kingdom , United Arab Emirates , Anne Hennecke Caroline Bergmann , Paul Sagan , Simon Conway Natalie , Stefan Weber , Valentin Handschin , Mc Services , European Union , Newron Pharmaceuticals , Drug Administration , Supernus Pharmaceuticals , Swiss Exchange , Abbreviated New Drug Application , Notice Letters , Drugs Product List , Orange Book , Meiji Seika , Natalie Garland Collins , Caroline Bergmann , தெற்கு கொரியா , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் ,

Newron Pharmaceuticals S.p.A.: Newron Announces Paragraph IV ANDA Filing for Xadago (safinamide) in the USA


Newron Pharmaceuticals S.p.A.: Newron Announces Paragraph IV ANDA Filing for Xadago (safinamide) in the USA
Newron Pharmaceuticals S.p.A. ( Newron ) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that it received a Paragraph IV Notice Letter regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents. ....

Kyongsang Bukto , South Korea , United States , United Kingdom , United Arab Emirates , Anne Hennecke Caroline Bergmann , Paul Sagan , Simon Conway Natalie , Stefan Weber , Valentin Handschin , Mc Services , European Union , Newron Pharmaceuticals , Drug Administration , Supernus Pharmaceuticals , Swiss Exchange , Abbreviated New Drug Application , Notice Letter , Drugs Product List , Orange Book , Meiji Seika , Natalie Garland Collins , Caroline Bergmann , தெற்கு கொரியா , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் ,

Newron announces results of explanatory studies with evenamide in healthy volunteers and patients with schizophrenia


DGAP-News: Newron Pharmaceuticals S.p.A.
/ Key word(s): Study results
01.04.2021 / 07:00
Newron announces results of explanatory studies with evenamide in healthy volunteers and patients with schizophrenia
Primary objective of safety of evenamide met on all safety variables for study 010 in healthy volunteers and study 008 in patients with schizophrenia
Additional safety and efficacy study 008A in therapeutic dose (30 mg BID) to start in April 2021
Milan, Italy and Morristown, NJ, USA, April 1, 2021 - Newron Pharmaceuticals S.p.A. ( Newron ) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced initial results from two short-term explanatory studies in evenamide: study 010 in healthy volunteers and study 008 in patients with schizophrenia. ....

Kyongsang Bukto , South Korea , United States , United Kingdom , United Arab Emirates , Ravi Anand , Anne Hennecke Caroline Bergmann , Paul Sagan , Simon Conway Natalie , Stefan Weber , Valentin Handschin , Mc Services , Newron Pharmaceuticals , Drug Administration , Swiss Exchange , Distribution Services , European Union , Supernus Pharmaceuticals , International Council , Technical Requirements , Human Use , New Chemical Entity , Meiji Seika , Natalie Garland Collins , Caroline Bergmann , Corporate News ,