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The FDA is proposing a new test to estimate the similarity between brand drugs and their generic equivalents, taking into account the variability in source brand drugs when deciding whether to grant generic drug applications, agency sources said.
None of the criteria the FDA’s Office of Generic Drugs (OGD) uses to determine whether it can issue a clinical trial waiver for a generic drug are applicable to ViroPharma’s gastrointestinal antibiotic Vancocin, company executives said July 13.
The FDA may have changed its bioequivalence testing standards for generic firms seeking to market versions of the antibiotic Vancocin, according the drug’s distributor.
Canadian drug firm Biolyse Pharma has started mining Canadian evergreens for the main ingredient in antiviral Tamiflu — shikimic acid — and said it is poised to supply the ingredient to other drugmakers and governments in countries where Tamiflu isn’t patented.
Ranbaxy Laboratories plans to conduct new clinical studies in North America for its generic antiretroviral fixed-dose combination (FDC) HIV treatments to definitively establish their bioequivalence, company officials said.