Riyadh, Jumada II 11, 1439, February 27, 2018, SPA -- Saudi Food and Drug Authority (SFDA) has announced a cancellation of registrations of four products because two of them are not bioequivalent
to the reference product, and the other two products have not been marketed for more than two years.
Is there a scientific rationale for making drug products with 'comparable' bioavailability, although not being proven bioequivalent
products, interchangeable with each other?
Greenstone recently rolled out amoxicillin 875-mg tablets, USP, AB-rated and bioequivalent
to Amoxil; cefadroxi1 500-mg capsules, USP, AB-rated and bioequivalent
to Duricef; cefdinir 300-mg capsules, AB-rated and bioequivalent
to Omnicef; and cefprozil 250- and 500-mg tablets, USP, AB-rated and bioequivalent
Results of the study indicate that the MetControl Metformin chewing gum and traditional Metformin tablets are bioequivalent
in respect of both the rate and the extent of systemic absorption such that MetControl and Metformin tablets are therapeutically equivalent and therefore interchangeable.
Under data exclusivity, a controversial rule first imposed in 1987, for a period of about eight years after approval of a new drug, a country cannot accept an application for a generic bioequivalent
to a brand-name drug even if the patent is expired or is otherwise not a problem, because that is called "unfair" use of the knowledge that the brand-name drug worked in the first place.
812) would let the Food and Drug Administration approve generic drugs that are not bioequivalent
to their brand-named counterparts.
Fluocinonide E Cream is bioequivalent
to Medicis' Lidex(R), and the market for this product is estimated by industry sources to be approximately $5,000,000.
Recent approvals include paroxetine tablets, bioequivalent
to GSK's Paxil; benzonatate (100- and 200-mg) capsules, bioequivalent
to Forest Laboratories Inc.
Diflorasone Diacetate Cream is bioequivalent
to Dermik Laboratories' Psorcon(R) Cream.
Recently launched products include Zolpidem Tartrate tablets, AB-rated and bioequivalent
to sanofi-aventis' Ambien; Azithromycin for injection; Cabergoline tablets, AB-rated and bioequivalent
to Pfizer's Dostinex; and Moexipril Hydrochlorothiazide tablets, AB-rated and bioequivalent
to Schwarz Pharma's Uniretic.