Par Pharmaceutical announced that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for fluvoxamine maleate 100mg and 150mg extended-release (ER) capsules. Fluvoxamine maleate ER is the generic version of Jazz Pharmaceuticals‘ Luvox CR indicated for the treatment of obsessive compulsive disorder.
Par was the first company to have submitted a substantially complete ANDA containing a paragraph 4 certification for fluvoxamine maleate 150 mg ER capsules. The company has been awarded 180 days of marketing exclusivity for fluvoxamine maleate 150mg ER capsules.
Par Pharmaceutical has begun shipping all approved strengths of the product.
For more information call (800) 828-9393 or visit www.parpharm.com.