Endo ships generic Sabril following FDA approval

Endo International plc of Dublin, Ireland recently launched shipping operations for its generic Sabril (vigabatrin for oral solution USP, 500 mg) product via Par Pharmaceutical, following final approval of its Abbreviated New Drug Application (ANDA).


The product is indicated as an anti-epilectic drug; it is currently the sole existing generic formulation and is available only by prescription.


"We are pleased to be able to offer patients a cost-effective option to Sabril," said  Par Pharmaceutical’s president Tony Pera. "Par's vigabatrin for oral solution is therapeutically equivalent to the brand and is therefore substitutable. We are proud to continue our tradition at Par of providing high quality, affordable medicines."


Vigabatrin is the generic ingredient in two branded drugs marketed by Lundbeck Pharms LLC as well as Par Pharm Inc. The branded Sabril product gained FDA approval in 2009.  FDA approval for this generic version does not necessarily guarantee immediate commercial availability.


Endo specializes in generics and specialty brands, focusing on bringing high quality medication to patients through high production and distribution standards. Its U.S. headquarters are located in Malvern, Pennsylvania.


Par Pharmaceuticals, affiliated with Endo as its operating company and located in Chestnut Ridge, New York, advances research and development for new products.

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https://www.drugpatentwatch.com/p/generic-api/vigabatrin




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Organizations in this story

Endo Pharmaceuticals, Inc. 1400 Atwater Dr Malvern, PA - 19355