Novadoz Pharmaceuticals issued the following announcement on June 4.
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, located in Hyderabad India, recently received FDA approval for their generic versions of Oseltamivir Phosphate Capsules and Dofetilide Capsules.
The company was notified earlier this year, that Dofetilide 125mcg, 250mcg, 500mcg capsules, AB rated to Pfizer's brand Tykosin©, received final approval from the agency. Dofetilide is an antiarrhythmic drug used sustain a normal heart beat in patients with certain heart rhythm disorders of the atrium. It is used to treat atrial fibrillation, or atrial flutter. Recent published data reports combined brand and generic sales for the product exceeded $63.4 MIL. The total unit sales have increased approximately10% over the preceding 12 month period. The company anticipates shipping the product shortly.
Most recently, Novadoz/MSN, received approval for Oseltamivir Phosphate 30mg, 40mg, and 75mg capsules, AB rated to Genentech Pharmaceuticals' Tamiflu©. The product is used to treat symptoms caused by the flu virus (influenza) that include blocked nasal passages, fever/chills, aches, and fatigue. Combined 12 month sales data for brand and generics was over $188 MIL. As a seasonal therapy, sales for the product may fluctuate depending on the severity of the flu season. Due to a higher than average number of reported flu cases over the past 12 months, product sales increased 46% over the previously reported 12 month period.
Seshu Akula, Novadoz President North America Generics, states, "MSN's FDA approvals for generic Dofetilide and Oseltamivir capsules continues to demonstrate the strength of the organization's R&D capabilities. Being vertically integrated with API provides the scale and supply chain surety that customers seek when selecting a partner for a potentially high volume seasonal products including Oseltamivir. We look forward to gaining several more important FDA approvals over the next 12 months."
MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates. MSN is the global leader in this category. Additionally, the company also manufactures finished dose oral solids, liquids, and specialty injectable products in 65 markets throughout the world, doing business in the U.S. as Novadoz Pharmaceuticals.
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