Look out: Another FDA import ban has come. Apotex, Canada's biggest drugmaker, has seen its products stopped at the U.S. border after a plant inspection identified deviations from manufacturing rules. Problems at Apotex's Etobicoke facility were detailed in a June 25 warning letter, which contended that Apotex did not thoroughly investigate its own manufacturing failures and that an unusual number of batches ended up rejected.
The import ban affects a number of drugs made at two plants, mostly older products with lots of competitors, Reuters reports, so shortages shouldn't be a problem. Among the drugs cited are generic versions of diltiazem, a blood pressure and angina remedy. An analyst told clients that the ban only applies to new shipments. "While details are still limited, it is our understanding that products already in inventory in the U.S. can be shipped to customers," Adam Greene of RBC Capital Markets wrote in an investor note (as quoted by Reuters), "but new product cannot be shipped to the U.S. until the ban has been lifted."
In a statement, Apotex said it is "actively working with the FDA to resolve" the problems. In this it's not alone; the FDA has been on something of a manufacturing crackdown of late, stopping more than one company's products from entering the U.S. The agency barred a slew of Ranbaxy Laboratories drugs late last year, and since not only barred meds from Caraco Laboratories, a subsidiary of India's Sun Pharmaceutical, but also seized some of the company's products as well.
- see the Apotex release
- check out the FDA warning letter
- read the Globe & Mail article
- get more from Reuters