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U.S. Department of Health and Human Services

Animal & Veterinary

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2009 Action Letter - NADA 101-479 Banamine® (flunixin meglumine) Injectable Solution

April 9, 2009

NADA 101-479 [(b)(4)]

Dr. Martin Tiemann
Director Pharmacovigilance and Product Stewardship
Intervet/Schering-Plough Animal Health
29160 Intervet Lane
Millsboro, DE, 19966 USA

RE: NADA 101-479 Banamine® (flunixin meglumine) Injectable Solution

Dear Dr. Tiemann:

The Center for Veterinary Medicine (CVM) has reviewed the promotional pieces SPAH-BA-6, 76R, 130D, 130A, and 164B for Banamine® Injectable Solution, NADA 101-479, submitted by Schering-Plough Animal Health under cover of form FDA 2301 dated July 14, 2008. We also reviewed the website, http://www.banamine.com. These promotional pieces, as well as your website, promote Banamine® for new intended uses that are not the subject of the approved new animal drug application (NADA). When promoted for these new unapproved intended uses, Banamine® is unsafe within the meaning of section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 360b(a)(1)], and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].

Background

Banamine® (flunixin meglumine) Injectable Solution is a non-steroidal analgesic agent with anti-inflammatory and anti-pyretic activity. The approved labeling contains the following indications for cattle:

Banamine Injectable Solution is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Banamine Injectable Solution is also indicated for the control of inflammation in endotoxemia.

Unapproved Claims

The promotional piece SPAH-BA-130D contains the statement, “It (Banamine) is approved for controlling pyrexia associated with acute mastitis in dairy cows. It also reduces irreversible lung consolidation that can result from the lung inflammation associated with BRD.” Although the first sentence of this statement is consistent with the approved label, the second sentence implies that reducing irreversible lung consolidation is also an approved indication for use. In fact, Banamine® is not indicated for reducing lung consolidation or controlling inflammation associated with bovine respiratory disease.

The promotional pieces SPAH-BA-130A and SPAH-164B contain the statement, “When it comes to reducing this irreversible lung consolidation, veterinarians and producers trust the original non-steroidal anti-inflammatory (NSAID), Banamine®.” (Footnote omitted.) As stated above, Banamine® is not indicated for reducing lung consolidation.

The banamine.com website, under “Usage Reports,” contains several promotional articles which have claims for which Banamine® is not approved.

  • The article, “Research Shows Advantage of Using Banamine with Conventional Therapy,” contains the statements:

    “In yet another study – this one in Nebraska involving 66 mixed-breed beef cattle – Banamine also significantly reduced lung consolidation in cattle suffering from BRD.”

    "Lung consolidation and its extent is an important consequence of BRD and is associated with reduced growth rates and increased relapse and reinfection rates …. The anti-endotoxin properties of Banamine may be responsible for the significantly lower percent lung consolidation measured in treated animals."

  • The article “Practitioners See Many Potential Uses for Newly Approved Anti-Inflammatory Agent for Cattle,” contains the statements:

    “Banamine reduces fever and inflammation, controls endotoxemia in BRD cattle.”

    “Banamine may be helpful in reducing the fever and inflammation associated with BRD.”

  • The article “Like a Grenade in an Ammunitions Depot” contains the statement:

    “Banamine has been shown to reduce lung lesions associated with BRD which are associated with reduced weight gain….”

  • The article, “Anti-Inflammatory Speeds Recovery in Cattle with Bovine Respiratory Disease,” contains the statements:

    “Recovery time in cattle with bovine respiratory disease can be vastly improved by administering a nonsteroidal anti-inflammatory with an antibiotic ....”

    “The anti-inflammatory is “definitely” improving time to market that otherwise would be lost.”

The website http://www.banamine.com/new/index.asp (What’s New) also contains four promotional pieces with unapproved claims:

  • The promotional piece entitled, “Just because your calves have BRD is no reason for them to go off feed,” contains the statement:

    “Feedyard managers had the strong opinion that Banamine reduces fever and that cattle get back on feed sooner because they feel better.”

  • The promotional piece entitled, “Finish Line Feeders,” contains the statement:

    “Intervention with Banamine reduces inflammation and endotoxemia leading to lung lesions.”

  • The promotional piece entitled, “Once Clyde was treated with Banamine, his penmates didn’t stand a chance in the feedyard’s weekly endurance races,” contains the statement:

    “Prescribe Banamine with your antibiotic of choice to reduce inflammation and endotoxemia leading to lung lesions.”

  • The promotional piece entitled, “The calves from hospital pen J-14 felt so much better after Banamine®, they couldn't wait for the morning feed run,” contains the statement:

    “Banamine controls the fever and inflammation associated with bovine respiratory disease and helps restore appetite. In most cases, you’ll see vast improvement in eating behavior within 12 hours of administration."

The banamine.com website at http://www.banamine.com/snapshot/aane.html (Snapshot) includes an article entitled, “Antibiotics are not Enough,” which contains the statement:

“Cattle with bovine respiratory disease (BRD) usually go off feed. Two reasons for this are fever and lung inflammation. The bacteria that cause BRD produce toxins. Those toxins cause the fever and lung inflammation associated with BRD.
Those toxins make cattle feel sick and go off feed. In many cases these circumstances lead to costly chronics and mortalities. Banamine can change that.”

The above statements do not accurately reflect the approved conditions for use of Banamine in cattle. The conditions for use of Banamine® specify that Banamine® is indicated for the control of pyrexia (fever) associated with bovine respiratory disease, endotoxemia and acute bovine mastitis, and for the control of inflammation in endotoxemia in cattle. Banamine® is not indicated for the reduction of fever and inflammation in all situations. Nor is Banamine® indicated for the treatment, control or reduction of endotoxemia in cattle, but rather for the control of inflammation in endotoxemia in cattle. In addition, Banamine® is not approved for any production claims. Further, Banamine® is not approved for the treatment of anorexia, the prevention of lung lesions or lung consolidation, nor for use in conjunction with other therapy, such as antibiotics.

We also note that at the end of the article entitled, “Like a Grenade in an Ammunitions Depot,” is a paragraph containing dosing information. Although the paragraph is presented in the context of discussions about bovine respiratory disease, the paragraph should be clarified to reflect that the dosage described is for control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia. This clarification is recommended because there is a different dosage in the approved labeling for control of pyrexia associated with acute bovine mastitis.

In addition, we note that the promotional pieces SPAH-BA-6 and 76R contain an outdated package insert for Banamine®. The current approved labeling is dated 2003 and includes all currently approved indications for use. We recommend that you update this piece to contain the correct version of the approved labeling.

Conclusion and Requested Actions:

These unapproved claims in promotional pieces for Banamine®, including those appearing on your website, cause the drug to be unsafe within the meaning of section 512(a)(1) of the Act [21 U.S.C. § 360b(a)(1)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].

CVM requests that Schering-Plough Animal Health immediately cease the dissemination of violative promotional pieces for Banamine® such as those described above. Future promotional labeling and advertisements including those posted on internet sites should accurately represent the facts regarding the approved indications for use of Banamine® in cattle. Please submit a written response within thirty (30) days of receipt of this letter describing your intent to comply with this request. Please direct your response to me at the Food and Drug Administration, Division of Surveillance, HFV-216, 7519 Standish Place, Rockville, MD 20855. We remind you that only written communications are official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that the promotional material for Banamine®, as well as other Schering-Plough Animal Health products, complies with the requirements of the Act and FDA implementing regulations.

If you have any questions, please contact me at the address above, or call me at (240) 276-9061. All future written correspondence regarding this matter should reference our file number NADA 101-479 (L00306).

Sincerely yours,

/s/

Lynn O. Post, D.V.M., PhD, DABVT
Director, Division of Surveillance
Center for Veterinary Medicine
cc:

Fred Hassan
Chairman of the Board and Chief Executive Officer
Schering-Plough Corporation
2000 Galloping Hill Road
Kenilworth, N.J. 07033-0530