Generics
Breckenridge wins FDA final approval for Rivastigmine Transdermal System ANDA
3 December 2019 -

Pharmaceutical company Breckenridge Pharmaceutical Inc revealed on Monday the receipt of US Food and Drug Administration final approval for its Abbreviated New Drug Application for Rivastigmine Transdermal System in 4.6mg/24 hours, 9.5mg/24 hours and 13.3mg/24 hours strengths.

The Rivastigmine Transdermal System in 4.6mg/24 hours, 9.5mg/24 hours and 13.3mg/24 hours strength is the generic for Exelon Patch by Novartis. Breckenridge plans to launch the product with immediate effect.

Rivastigmine Transdermal System was developed in collaboration with Welding GMBH & Co KG, SK Chemicals Co Ltd and Breckenridge.

For the 12 months ending 30 September 2019, the Exelon Patch and its therapeutic equivalents generated annual sales of USD161m according to industry sales data.

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