Asks pharma major to recall a batch of Quetiapine Fumarate tablets citing the failed dissolution test requirements
The US Food and Drug Administration (USFDA) has asked Dr Reddy's Laboratories (DRL) to recall a batch of anti-psychotic drug Quetiapine Fumarate tablets of 25 mg, citing the failed dissolution test requirements.
The Hyderabad-based pharmaceutical major had launched its generic Quetiapine Fumarate tablets in the US market in March this year following the approval by the USFDA.
Used to treat Schizophrenia or bipolar disorder, the drug is a bioequivalant version of AstraZeneca's blockbuster drug Seroquel, which had sales revenues of $4.6 billion in the US market for the year ended December 2011.
Referring to a particular lot (C203090 expiry 03/2014) of the drug, the enforcement report putout by the USFDA said that during the analysis of long term stability studies at three-month time point, an OOS (out of specification) was reported for Quetiapine Fumarate tablets.
"This was something that happened in September this year. It was a very small batch and has no significance what so ever on Dr Reddy's sales of Quetiapine Fumarate tablets in the US market," said a company representative on condition of anonymity.
The company had produced the drug at its Bachupally facility near Hyderabad, according to the USFDA enforcement report.
This is a latest case of drug recall by an Indian company following the Ranbaxy Laboratories' voluntary recall of a few batches of its Lipitor generic drug and Aurobindo Pharma's voluntary recall of a batch of Zolpidem from the US market this year.
Two other Indian companies, Sun Pharmaceutical and Lupin had also received USFDA approval to launch Quetiapine Fumarate in the US market around the same time as Dr Reddy's.
DRL's scrip was trading at Rs 1,820 on the BSE today, up by Rs.11.20 or 0.62% over the previous day's close.
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