A generic drug which treats Alzheimer’s disease has been submitted to the Food and Drug Administration in the US for approval to market it
India-based drugs giant Sun Pharmaceutical Industries announced on Saturday its US-based subsidiary has been given provisional approval from the government department to sell the drug.
An abbreviated new drug application has been been submitted by Sun Pharma to produce both 5mg and 10mg doses of Memantine tablets. Memantine are the same as Forest Laboratories’ patented Namenda tablets which can treat moderate to severe Alzheimer’s disease .
The Sun Pharma subsidiary was established in 1983 with just five products and since 1996 has been acquiring other drugs firms and expanding. In 2008, it had 8,000 workers worldwide, as well as 19 factories, two research centres and a base in 30 countries.
Copyright Press Association 2010
US Food and Drug Administration