USFDA nod for Ranbaxy generic drug

USFDA nod for Ranbaxy generic drug
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First Published: Tue, Feb 10 2009. 10 24 PM IST
Updated: Tue, Feb 10 2009. 10 24 PM IST
New Delhi: Pharmaceutical company Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to launch the generic version of GlaxoSmithKline Plc.’s (GSK) anti-migraine medicine Imitrex.
“We have received the FDA’s approval to launch the 100mg strength of sumatriptan,” confirmed a Ranbaxy spokesperson. The company had re-filed the approval application from its plant in the US after FDA banned two of its India facilities.
But Dr Reddy’s Laboratories Ltd (DRL) had launched all three strengths (25mg, 50mg and 100mg) of sumatriptan in the US in November after a litigation settlement with GSK.
“They are late in game. While DRL has already made $73 million (Rs355 crore) from the sale of Imitrex, Ranbaxy may not make more than $20-30 million,” said Ranjit Kapadia, head of research, private client group, at brokerage Prabhudas Lilladher Pvt. Ltd.
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First Published: Tue, Feb 10 2009. 10 24 PM IST