US FDA approves Sun Pharmaceutical''s Novartis-equivalent generic Exelon capsules for US markets
24 Oct 2007
The US Foods and Drug Administration
has granted its final approval for Sun Pharmaceutical''s abbreviated new drug application
(ANDA) to market its generic version of Novartis Exelon, rivastigmine tartrate
capsules.
These generic rivastigmine capsules are AB-rated equivalent of Novartis Exelon Capsules and include four strengths: 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base). These strengths of Exelon® have annual sales of approximately USD 200 million in the US.
Sun
Pharma, being one of the first-to-file an ANDA for generic Exelon with a para
IV certification, shares a 180-day marketing exclusivity, in view of the ongoing
litigation with Novartis on this product, and is evaluating its launch options.
Rivastgmine tartrate is indicated for the treatment of mild to moderate dementia
of the Alzheimer''s type and for the treatment of mild to moderate dementia associated
with Parkinson''s disease.