India's Dr. Reddy's Laboratories is having to recall both an epilepsy drug and a combo cardiovascular drug all made in India. One, the FDA says, is too strong while the other is not strong enough. The recalls come even as the FDA has been paying special attention to generic equivalence after testing has found evidence that some generics are not measuring up.
According to the FDA's most recent Enforcement Report, Dr. Reddy's is recalling four lots of divalproex sodium ER, an extended-release generic of Abbott Laboratories' ($ABT) epilepsy drug, Depakote. The report said Dr. Reddy's is voluntarily recalling different doses of the drug after testing found that it exceeded specifications at 9 hours. The company additionally is recalling 6 lots of different dose sizes of amlodipine besylate and atorvastatin, a generic of the Astellas heart combo drug Caduet. In that case, the drug was found to be subpotent, the report says.
According to the notice, the drugs were all manufactured at Dr. Reddy's plant in Bachupally, India. The plant is one of a number in which Dr. Reddy's has invested in upgrades to try to automate processes to raise quality. Last year, the Indian drugmaker recalled 13,560 bottles of metoprolol succinate extended-release tablets, a generic of AstraZeneca's ($AZN) blood pressure med Toprol XL, because it had failed dissolution testing in an 18-month check. It was also manufactured at the plant in Bachupally.
The FDA has been paying closer attention to bioequivalence after hearing reports that some generics do not work as well as the brands they copy. Last fall, the FDA gave two drugmakers a 6-month deadline to show that their generics of Johnson & Johnson's ($JNJ) ADHD med Concerta were equivalent after tests found that the copies from Mallinckrodt Pharmaceuticals ($MNK) and UCB wore off more quickly than the brand specifications require. A generic sold by Actavis but manufactured by J&J was found to be equivalent.
The New York Times recently pointed out that that deadline has come and gone and the copies in question are still on the market. UCB says it has submitted new information to the agency that shows its generic is equivalent to Concerta. Mallinckrodt sued the FDA to try to stop the action.
- the divalproex recalls are here and here
- the amlodipine besylate and atorvastatin calcium tablets recalls are here, here, here and here