Sun Pharma Gets FDA Approval For Generic Namenda Tablets
Sun claims that it was amongst the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification to the 703 patent. Sun's subsidiary is eligible for 180 days generic exclusivity.
These generic Memantine tablets are equivalent to Forest Laboratories' Namenda tablets and include two strengths: 5 mg and 10 mg. These strengths of Memantine have a combined annual sale of approximately $1.2 billion in the US. Memantine tablets are indicated for the treatment of moderate to severe Alzheimer's Disease.
Do you think this approval will help Sun Pharma?
Have your say and discuss with your peers on the InfoGrok community.
Participate by posting your comments now.