HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)-- 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 Vigabatrin Powder for Oral Solution, USP in 500 mg per packet, a therapeutic equivalent generic version of Sabril® (vigabatrin) Powder for Oral Solution, USP, approved by the U.S. Food and Drug Administration (USFDA).
The Sabril® brand and generic had U.S. sales of approximately $274 million MAT for the most recent twelve months ending in June 2019 according to IMS Health*.
Dr. Reddy’s Vigabatrin Powder for Oral Solution, USP is available in 500 mg per packet in count size of 50 per carton.
WARNING: PERMANENT VISION LOSS
See full prescribing information for complete boxed warning.
- Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin may also decrease visual acuity.
- Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to vigabatrin known to be free of risk of vision loss.
- Risk of new and worsening vision loss continues as long as vigabatrin is used, and possibly after discontinuing vigabatrin for oral solution.
- Baseline and periodic vision assessment is recommended for patients on vigabatrin. However, this assessment cannot always prevent vision damage.
- Vigabatrin for oral solution is available only through a restricted program called the Vigabatrin REMS Program.
Sabril® is a trademark of Lundbeck.
*IMS National Sales Perspective: Retail and Non-Retail MAT June 2019
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