Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for generic Razadyne tm, galantamine tablets.
Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
These generic versions of galantamine are bio-equivalent to Razadyne tm distributed by Ortho-McNeil Neurologics, Inc. The ANDA includes three strengths: tablets containing galantamine hydrobromide equivalent to 4mg, 8 mg and 12 mg base.
These strengths of branded galantamine have annual sales of approximately USD 120 million in the US.
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