March 23, 2009
Manager, Pharmaceutical Regulatory Affairs
Fort Dodge Animal Health
Division of Wyeth
800 5th Street, NW
Fort Dodge, Iowa 50501
RE: NADA 141-087 Quest® (moxidectin) 2% Equine Oral Gel and NADA 141-216 - Quest® Plus (moxidectin/praziquantal) Equine Oral Gel; PowerPoint Presentations entitled “Making a Difference in the Life of Your Horse” and “Equine Parasites”
Dear Ms. Hokinson:
The U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Division of Surveillance has reviewed your August 4, 2008, Drug Experience Report (DER) concerning Quest® (moxidectin) 2% Equine Oral Gel, NADA 141-087 and Quest® Plus (moxidectin/praziquantal) Equine Oral Gel, NADA 141-216. This submission includes a Power Point Presentation entitled "Making a Difference in the Life of your Horse" and a Power Point Presentation entitled "Equine Parasites." According to your submission, “Product will be available where [these presentations are] shown.” Therefore, FDA considers these presentations to be labeling within the meaning of section 201(m) [21 U.S.C. § 321(m)] of the Federal Food, Drug, and Cosmetic Act (the Act). We consider these promotional materials to be misleading because they fail to reveal relevant risk information, thus causing the drugs to be misbranded within the meaning of sections 502(a) [21 U.S.C. § 352(a)] and 201(n) [21 U.S.C. § 321(n)] of the Act.
Quest® (moxidectin) 2% Equine Oral Gel and Quest® Plus (moxidectin/praziquantal) Equine Oral Gel are approved for the treatment and control of the following stages of gastrointestinal parasites of horses and ponies six months of age and older:
- Large strongyles: Strongylus vulgaris (adult and L4/L5 arterial stages), Strongylus edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), Triodontophorus serratus (adults)
- Small strongyles (adults): Cyathostomum spp. including C. catinatum, C. pateratum; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, C. minutus; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus; C. radiatus; Coronocyclus spp. including C. coronatus, C. labiatus, C. labratus; Gyalocephalus capitatus; Petrovinema poculatus
- Small strongyles: undifferentiated luminal larvae;
- Encysted cyathostomes: late L3 and L4 mucosal cyathostome larvae;
- Ascarids: Parascaris equorum (adults and L4 larval stages);
- Pinworms: Oxyuris equi (adults and L4 larval stages);
- Hairworms: Trichostrongylus axei (adults);
- Large-mouth stomach worms: Habronema muscae (adults);
- Horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars), G. nasalis (3rd instars)
- One dose also suppresses strongyle egg production through 84 days.
In addition, Quest® Plus (moxidectin/praziquantal) Equine Oral Gel is approved for the treatment and control of adult Tapeworms (Anoplocephala perfoliata).
The FDA-approved labeling for both Quest® (moxidectin) 2% Equine Oral Gel and Quest® Plus (moxidectin/praziquantal) Equine Oral Gel contain the following statements:
In the Warnings section:
Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals. Not for horses or ponies intended for human consumption.
In the Precautions section:
[This product] has been formulated specifically for use in horses and ponies only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.
Omission of Risk Information
The power point presentations fail to include any risk information regarding possible side effects and contraindications associated with administration of Quest® (moxidectin) 2% Equine Oral Gel and Quest® Plus (moxidectin/praziquantal) Equine Oral Gel. As noted above, improper use of Quest® Gel and Quest®Plus Gel may result in serious adverse reactions. The labels for both Quest® (moxidectin) 2% Equine Oral Gel and Quest® Plus (moxidectin/praziquantal) Equine Oral Gel clearly state a number of serious risks associated with incorrect use of these products. However, the promotional labeling pieces do not contain any of these warning or precaution statements. The failure to include these warning and precaution statements in the power point presentations is misleading because, without the statements, these promotional labeling pieces fail to reveal material facts with respect to consequences which may result from the use of Quest®(moxidectin) 2% Equine Oral Gel and Quest® Plus (moxidectin/praziquantal) Equine Oral Gel. See 21 U.S.C. § 321(n). Therefore, these promotional pieces cause the drugs to be misbranded within the meaning of sections 502(a) [21 U.S.C. § 352(a)] and 201(n) [21 U.S.C. § 321(n)] of the Act.
The presentation "Equine Parasites" contains a slide entitled "Summary," which contains the following statement about Quest® and Quest Plus®: "Environmentally friendly -- does not impact dung beetle populations.” However, according to the label for Quest® and Quest Plus®, "Care should be taken to avoid the release of significant volumes of moxidectin into either ground or free-running water since moxidectin may be injurious to aquatic life. SURE-DIAL® syringes and their contents should be disposed of in an approved landfill or by incineration.” Therefore, the claim that the products are "Environmentally friendly” is misleading and causes your products to be misbranded within the meaning of section 502(a) [21 U.S.C. § 352(a)] of the Act.
Conclusion and Requested Action
The lack of safety information and the misleading statement regarding the environmental impact of Quest® and Quest Plus® misbrand your products within the meaning of sections 502(a) [21 U.S.C. § 352(a)] and 201(n) [21 U.S.C. § 321(n)] of the Act.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to see that your promotional materials for Quest® Gel and Quest®Plus Gel, as well as for other Fort Dodge Animal Health products, comply with the requirements of the Act and FDA implementing regulations.
The Center for Veterinary Medicine requests that Fort Dodge Animal Health immediately cease the dissemination of the promotional items described above and any other materials that may contain similar promotional claims. Please submit a written response within thirty (30) days of receipt of this letter describing whether you intend to comply with this request, and listing all violative promotional materials for Quest® Gel and Quest®Plus Gel the same as or similar to those described above, and explaining your plan for discontinuing use of such materials.
Please direct your response to me at the Food and Drug Administration, center for Veterinary Medicine, Division of Surveillance, HFV-210, 7519 Standish Place, Rockville, MD 20855. We remind you that only written communications are official.
Lynn O. Post, DVM, PhD, DABVT
Director, Division of Surveillance
Center for Veterinary Medicine
President/Director/CEO/Chairman of the Board