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    Granules India arm wins USFDA approval for stimulant drug Amphetamine Sulfate tablets

    Medical Dialogues BureauWritten by Medical Dialogues Bureau   |  

    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

    Abbreviated New Drug ApplicationADHAAmphetamine Sulfate tabletsANDAArbor PharmaArbor Pharmaceuticalsattention deficit hyperactivity disorderEvekeo tabletsgeneric central nervous systemGranules IndiaGranules PharmaceuticalsGranules Pharmaceuticals Incimpulsivenesspharmapharma newspharma news indiasleep disorderstimulant drugUSFDA nod
    Source : PTI

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    Medical Dialogues Bureau
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