Reference drugs for triple combination test drug in Russia [Design Issues]

posted by PharmCat  – Russia, 2019-11-18 22:47  – Posting: # 20825
Views: 848

» PharmCat, if we take triple combination e.g. Losartan 100 mg/Amlodipine 5 mg/Rosuvastatin 20 mg (mittyri`s real example) and following reference drugs Losartan 100 mg/Amlodipine 5 mg and Rosuvastatin 20 mg than still the compared drugs have the same qualitative composition and quantitative composition of active substances in the same dosage form as the reference drug as you said. it is still losartan 100 mg whenever you take it.

Sorry, but no. Ask how FDC registration performs in EU or FDA. Russian regulatory doesn't have guidance about FDC, but it coming as EEU document. ... in the same dosage form as the reference drug(not drugs). No such reference drug: Losartan+Amlodipine+Rosuvastatin, there are two drug: Losartan+Amlodipine and Rosuvastatin. We don't know nothing about new FDC - no safety, no efficacy data. This is new drug.

look here.

We are talking about scenario 1: new FDC-FPP contains the same actives in the same doses as an existing FDC-FPP; that is it is a “generic” of the existing FDC-FPP

existing examples do not confirm the fact - is it legal or not.

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