That’s The Way The Tablet Crumbles: Industry Protests FDA Friability Test
A split tablet’s structure is compromised by definition and shouldn’t be subjected to friability testing, drug manufacturers argue in response to an FDA draft guidance.
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Success of petition seeking to block single-scored generics of Doryx will likely rest on the brand firm's ability to make a safety and efficacy case for its dual-scored version of the antibiotic, which may be difficult given that it was marketed as a single-scored tablet for so long.
One of the intriguing elements of FDA’s draft guidance on tablet scoring is how it handles the relationship between brand and generic versions of the products.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.