A generic drug is defined as a drug that is interchangeable with the original reference drug, contains the same amount of the same active pharmaceutical ingredient (API), and has the same administration routes, indication, therapeutic effects, and dosage regimen as the original drug.
For this purpose, also UDD/ADD-ratios for administration routes and indications were calculated separately.
Any use of systemic drugs is clearly documented (time, doses, routes, and indications) and strictly followed by the physician.
In order to compare usage patterns for different animal groups, antimicrobials, administration routes and indications, for each record the UDD was divided by the ADD to obtain the UDD/ADD-ratio per record.
The increase of more passengers within a route is an indication where the transportation startup sees potential for growth.
Giles emphasized the importance of the route as an indication of the future, both for civil and military aircraft.
There is in fact an 'anti-evergreening' clause which explicitly provides no new exclusivity period would be granted for "a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength".
The clause Representative Eshoo refers to does appear on its face to exclude changes that result in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength from being eligible for a new 12-year exclusivity period.
We considered documents as relevant to off-label drug use, if they referred to any human drug outside the approval purposes, in terms of different dose, indication, route of application or for another age group.
No additional period of exclusivity will be granted to a previously licensed biologic product when subsequent applications are made for a new indication, route of administration, dosage form, or dosing strength.
