Zydus group firm Nesher Pharma gets USFDA nod for Dextroamphetamine IR tablets
New Delhi : Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals, USA has received approval from the US health regulator to market Dextroamphetamine IR tablets, used in treating nervous system disorders, in the American market.
Nesher has received its first abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) to market Dextroamphetamine IR Tabs, Zydus Cadila said in a statement.
"The drug falls in the CNS stimulant segment and is the first product to be developed by the R&D team at Nesher. It will be produced at the manufacturing facility based at St. Louis, Missouri, USA," it added.
As per IMS sales data, the estimated sales for Dextroamphetamine IR Tabs is $40.6 million.
Abbreviated New Drug ApplicationANDADextroamphetamine IR tabletsNesher PharmaSt. LouisUS Food and Drug AdministrationUSFDAzydus
Source : PTINext Story
NO DATA FOUND
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd