Ancillary Therapy COPY COPY

Question 1

What are we trying to accomplish with ancillary therapy for BRD?

Answer 1

• increase treatment response in conjunction with an antimicrobial? (more cattle respond with no need for continued therapy, also implies decreased mortality)
• Improve performance during the post-treatment period, even in the absence of ancillary treatment effects on treatment response or mortality
• Improve humane aspects of care for cattle afflicted with respiratory disease

Question 2

Are steroids a good options for additional treatment for BRD along with antimicrobials?

Answer 2

• No clinical data to support an imporvement in clinical response in light of potential adverse effects

Question 3

What is Flunixin Meglumine?

Answer 3

• NSAID currently labeled specifically for BRD in the US
• Label include indications for the control of pyrexia associated with bovine respiratory disease and endotoxemia
• for the control of inflammation in endotoxemia
• Considered an effective analgesic, anti-inflammatory, and antipyretic
• MOA: cyclo-oxygenase inhibition

Question 4

Is there evidence that NSAIDs are a good ancillary therapy for BRD?

Answer 4

• No
• Available literature of the use of steroids in BRD suggests detrimental or equivocal effects

Question 5

What is required in an Original (NADA) proprietary approval?

Answer 5

• Chemistry, Manufacturing, and Controls (CMC)
• Effectiveness
• Target animal safety
• food animal safety
• Environmental impact
• Labeling
• all other information

Question 6

What is required in a generic (ANADA) approval

Answer 6

• Labeling
• Chemistry, Manufacturing, Controls
• Human food safety
• Environmental impact
• Bioequivalence
• Patent and marketing Exclusivity

Question 7

When can ANADAs be approved?

Answer 7

• Once the pioneer drug is off patent, or in some cases after expiration of an additional marketing exclusivity period, the FDA is granted authority by the Generic Animal Drug and Patent Term Restoration Act of 1988 to approve Abbreviated New Animal Drug Applications (ANADAs) for generic copies of the pioneer drug

Question 8

What are the differences between NADAs and ANADAs

Answer 8

• The technical secions for effectiveness and target animal safety are not required for generic ANAdA applications. Bioequivalence studeis bridge the generic product to the pioneer product, which was proven to be safe and effective
• Technical sections unique to the generic drug approval are the Bioequivalence and Patent and Marketing Exclusivity

Question 9

What is a Biowaiver?

Answer 9

• All generic products must demonstrate bioequivalence
• For product where this is accomplished through approval of a biowaiver such as an injectable solution, bioequivalence may be demonstrated by a comparison of the generic formulation to the pioneer on the basis of relevan physiochemical properties
• If there are any changes in the generic product which affect bioavailability the biowaiver will be denied

Question 10

When are Bioequivalence Studies required?

Answer 10

• When a biowaiver is not granted, then a bioequivalence study is required
• We will use a pharmacokinetic (blood concentration) study, in some cases alternatives to this type of study may be used such as a pharmacologic end-point study or clinical end-point study

Question 11

What is the difference between a Pioneer/Generic drug and a compounded drug?

Answer 11

• A compounded product is not approved by any agency. none of the technical sections receiving approval by a pioneer/generic product are evaluated
• No studies assure efficacy or safety to either the treated animal or for the consumers of food products from the animal
• It is illegal to compound products for food animals from bulk products, which are products not having approval in veterinary or human medicine