Newron Pharmaceuticals SpA
Newron announces Paragraph IV ANDA filings for Xadago® (safinamide) in the USA
Newron Pharmaceuticals SpA / Key word(s): Miscellaneous Milan, Italy – May 20, 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 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. About Newron Pharmaceuticals End of ad hoc announcement |
Language: | English |
Company: | Newron Pharmaceuticals SpA |
Via Antonio Meucci 3 | |
20091 Bresso | |
Italy | |
E-mail: | info@newron.com |
Internet: | www.newron.com |
ISIN: | IT0004147952 |
Listed: | SIX Swiss Exchange |
EQS News ID: | 1198586 |
End of Announcement | EQS Group News Service |