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| Cymbalta--Courtesy of Eli Lilly |
Teva Pharmaceutical Industries ($TEVA) is one of half a dozen drugmakers that have been rolling out generics of Eli Lilly's ($LLY) top-selling blockbuster Cymbalta. The others are going to roll past the Israeli drugmaker after it recalled more than 1 million bottles of the antidepressant.
According to the FDA's weekly Enforcement Report for the week of April 9, Teva is voluntarily recalling a total of 19 lots of the extended-release version of duloxetine including 20-mg capsules in 60-unit bottles as well as 30-mg and 60-mg versions in 30-unit bottles. The report said that the drugs were all manufactured in Israel and were being recalled because of a customer complaint about capsule breakage. The total recall added up to 1,050,266 bottles.
In a statement emailed to FiercePharmaManufacturing, the company said: "The safety and efficacy of our medicines is one of Teva's top priorities. We recalled all impacted lots (19) and have identified and remediated the root cause of this recall. This has no material impact on the company."
While that is a lot of product, 5 other companies were approved in December to produce generics of Cymbalta: Aurobindo Pharma, Dr. Reddy's Laboratories, Lupin, Sun Pharma and Torrent Pharmaceuticals. Cymbalta was Lilly's top-selling drug, bringing in more than $5 billion last year. The Indianapolis, IN-based drugmaker started bracing itself for the hit last year by laying off or transferring 1,500 Cymbalta sales and marketing reps and freezing pay for most employees.
The recall pain for Teva does not stop there, however. The drugmaker is also recalling nearly 258,000 cylinders of its inhaled asthma drug Qvar. According to the recall notice, the product is manufactured for Teva by 3M Drug Delivery Systems of Northridge, CA. They are being voluntarily retrieved because the drug failed stability testing for impurity and degradation specifications at both the 9-month and 18-month time periods. Qvar is a substantial seller for Teva with 2013 revenues of $463 million, up 2%.
- the FDA duloxetine recall notifications are here, here and here
- the Qvar notification is here