Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Amphetamine Sulfate Tablets USP, a therapeutic equivalent generic version of Evekeo® (amphetamine sulfate) Tablets approved by the U.S. Food and Drug Administration (USFDA). Amphetamine Sulfate Tablets, USP is a Schedule II drug.
The Evekeo® brand and generic had U.S. sales of approximately $38 million MAT for the most recent twelve months ending in January 2020 according to IQVIA Health*.
Dr. Reddy’s Amphetamine Sulfate Tablets USP are available in 5 mg and 10 mg dose in bottle count sizes of 100.
Please see the full prescribing information including boxed warning.
https://www.drreddys.com/pi/Amphetamine_sulfate_tablets_USP_CII.pdf
WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
