Monday, November 29, 1999

Glenmark recalls child epilepsy drug in US

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New Delhi, June 17 (PTI) Indian pharma firm Glenmark is recalling specific lots of its Oxcarbazepine tablets, used for the treatment of child epilepsy, in the US over a labelling error. According to information available on US health regulator Food and Drug Administration''s website, "Firm initiated recall is ongoing." ". A typographical error was found in the ''How Supplied'' section of the package outsert, showing the wrong imprint description for 150 mg, 300 mg and 600 mg tabs," it said. When contacted, a company spokesperson declined to comment, saying it is a very small issue and has no revenue implication. As per the US FDA website, the company had written to the drug regulator in April about the recall of specific lots of the drug in two strengths -- 150 mg and 300 mg -- in bottles containing 100 tablets. The drug is being manufactured by Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals. Glenmark had received USFDA approval to sell generic Oxcarbazepine tablets in the US in 2007 in three strengths of 150 mg, 300 mg and 600 mg. Oxcarbazepine is a generic version of Novartis'' patented drug, Trileptal. The drug is estimated to have sales of over USD 700 million annually in the US market.

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