The market has been focused this week on the recall of generic Lipitor by Ranbaxy Laboratories but it turns out there was another Indian generics company that recently retrieved a key generic drug.
In September, the FDA made Dr. Reddy's Laboratories recall a batch of anti-psychotic drug quetiapine fumarate, which is its version of AstraZeneca's ($AZN) schizophrenia blockbuster Seroquel, the Business Standard reports. Dr. Reddy's launched the generic in March. The generic launch of Seroquel has done a lot of damage to AstraZeneca, which reported a 57% decline in Seroquel franchise sales in the first three months after the generics hit the market. That took sales to just $647 million, a loss of some $900 million.
In September, the publication said the FDA found that there were stability questions with a lot of Dr. Reddy's product. The Indian company downplayed the recall, saying "This was something that happened in September this year. It was a very small batch and has no significance whatsoever on Dr. Reddy's sales of quetiapine fumarate tablets in the U.S. market," a spokesperson told the publication. Dr. Reddy's has had manufacturing issues with other products. It had an import ban on a plant in Mexico lifted in July.
The disclosure comes as Dr. Reddy's much larger competitor has been dealing with serious recall issues. The FDA said yesterday that Ranbaxy was halting production of generic Lipitor while it explores how glass particles got into ingredients used in the pills. Last week it recalled 41 lots of the top-selling drug. It also was disclosed that the company in August recalled a single lot because a bottle that contained two different sizes of pills was found by a pharmacy.
- read the Business Standard story