Granules India arm wins USFDA approval for stimulant drug Amphetamine Sulfate tablets
Amphetamine Sulfate tablets is a generic version of Arbor Pharmaceuticals LLC's Evekeo tablets in similar strength, it added.
New Delhi: Drug firm Granules India on Tuesday said its US arm has received approval from the USFDA for a generic central nervous system stimulant drug, Amphetamine Sulfate tablets.
The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by the company's subsidiary, Granules Pharmaceuticals Inc, for Amphetamine Sulfate tablets USP 5 mg and 10 mg, Granules India said in a filing to BSE.
The product is a generic version of Arbor Pharmaceuticals LLC's Evekeo tablets in similar strength, it added.
Read Also: Granules India completes USFDA inspection for Bonthapally facility with one observation
"Amphetamine Sulfate tablets is a central nervous system stimulant used to treat a sleep disorder, increase attention, decrease impulsiveness and hyperactivity in patients with Attention Deficit Hyperactivity Disorder (ADHD)," Granules India said.
Read Also: Granules India gets USFDA nod for Methylphenidate Hydrochloride ER capsules
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