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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") (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 t...

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 safin...

Optimus Pharma launched a new Anti-Parkinson's Drug in India ANI | Updated: Apr 26, 2021 12:10 IST Hyderabad (Telangana) [India], April 26 (ANI/PNN): Optimus Pharma has announced today that it has received DCGI approval for its Anti-Parkinson's drug Safinamide. Safinamide is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. The burdens of Parkinson's Disease (PD) are undeniably serious and increasing while various unmet needs remain, especially the absence of disease-modifying th...