Novadoz gets FDA nod for generic Tamiflu, launches generic Tykosin

Sandra Levy
Senior Editor
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Novadoz has had a busy week. The company has received Food and Drug Administration approval for its generic of Tamiflu generic and launched its generic of Tykosin. Novadoz/MSN's generic of Tamiflu (oseltamivir phosphate capsules) has been approved in dosage strengths of 30 mg, 40 mg, and 75 mg. It is indicated to treat symptoms caused by the flu virus that include blocked nasal passages, fever/chills, aches, and fatigue. The brand and generic had a market value of over $188 million. The company anticipates shipping the product shortly.

"MSN's FDA approvals for generic dofetilide and oseltamivir capsules continues to demonstrate the strength of the organization's  R&D capabilities," said Seshu Akula, Novadoz president North America generics. "Being vertically integrated with [active pharmaceutical ingredients] 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."

Also, Novadoz is releasing its generic of Pfizer's Tykosin (dofetilide), an antiarrhythmic drug used to sustain a normal heartbeat in patients with certain heart rhythm disorders of the atrium. The product is available in 125 mcg, 250 mcg, and 500 mcg capsules. The brand and generic had a market value of more than $63.4 million.