Is Apotex warning one generics red flag too many?
How many warning letters will FDA have to send to generics makers before patients start doubting the quality of copycat meds? That's the question the New York Times asks today after Canadian drugmaker Apotex got another FDA warning about manufacturing deficiencies at its plants.
Of course, the Apotex warning letter--which detailed contamination problems with drugs for diabetes and allergy, among others--comes at a time when generics makers around the world have come under fire for manufacturing troubles.
For example, Indian drugmaker Ranbaxy Laboratories has had drugs barred from importation into the U.S. because of problems at two factories in its home country. And recently, the company got an FDA warning about manufacturing violations at a subsidiary plant in the U.S.
The Times notes that FDA had an advisory meeting this week to discuss whether generics might need to be regulated more tightly to help ensure that the public continues to trust that they're a viable alternative to branded meds.
- read the NYT piece
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