Communication to Feed Industry for Melegestrol Acetate

                                                                                         

To:  Feed Companies, Feed Manufacturers, Beef Consulting Nutritionists and Cattle Feed Formulation personnel involved with the beef cattle feeding industry

Subject: Clarification of Combination Approvals and Approved Melengestrol Acetate, Monensin, Tylosin, Ractopamine and Zilpaterol Combination Blue Bird Labeling for Type B and Type C feeds    

It has been brought to our attention at Zoetis that confusion may exist within the marketplace related to the combination approvals related to the use of melengestrol acetate, monensin, tylosin, ractopamine and zilpaterol sold in the market place as:

Melengestrol Acetate:

·        MGA 200® (dry Type A premix) and MGA 500® (liquid Type A premix) – Zoetis

·        HeifermaX® 500 (liquid Type A premix) – Elanco Animal Health

Monensin:

·        Rumensin 90® (dry Type A premix) – Elanco Animal Health

Tylosin:

·        Tylan 40® or 100® (dry Type A premix) – Elanco Animal Health

·        Tylovet 100® (dry Type A premix) – HuvePharma

Ractopamine:

·        Optaflexx 45® (dry Type A premix) – Elanco Animal Health

Zilpaterol:

·        Zilmax® (dry Type A premix) –Merck Animal Health

Melengestrol Acetate, Monensin and Melengestrol Acetate, Monensin and Tylosin - 2 and 3 way combinations ARE APPROVED in Type C Medicated Feeds to be fed on farm or in the feedlot. (See labels and/or APPROVED Type C Blue Bird labels for specific labeling and feeding instructions.) 

Melengestrol Acetate, Monensin and Melengestrol Acetate, Monensin and Tylosin – in combination with either Ractopamine or Zilpaterol in 3 or 4 way combinations ARE APPROVED in Type C Medicated Feeds to be fed on farm or in the feedlot. (See labels and/or APPROVED Type C Blue Bird labels for specific labeling and feeding instructions.) 

Confusion appears to exist in the market with Feed Companies, Feed Manufacturers, Consulting Nutritionists and Cattle Feed formulation personnel related to the manufacture and use of Type B Medicated Feeds containing:

1)      Melengestrol Acetate and Monensin (2 way combination)

2)      Melengestrol Acetate, Monensin and Tylosin (3 way combination)

3)      Melengestrol Acetate and Monensin and Ractopamine (3 way combination)

4)      Melengestrol Acetate, Monensin, Tylosin and Ractopamine (4 way combination)

5)      Melengestrol Acetate and Monensin and Zilpaterol (3 way combination)

6)      Melengestrol Acetate, Monensin, Tylosin and Zilpaterol (4 way combination)

There are currently NO approved Blue Bird labels for Type B Medicated Feeds to be manufactured in a single common Type B Medicated Feed product due to recent updates to expanded dose ranges for Monensin and Melengestrol Acetate under the interpretation of the 1996 Animal Drug Availability Act (ADAA) which allows for expanded combination approvals and updates published in the Code of Federal Regulations (CFR) 2013.

Thus the manufacture of Type B Medicated Feeds containing Melengestrol Acetate and any of the above mentioned feed additives in a common Type B Medicated Feed can NO longer be manufactured.

While the combinations of 1) melengestrol acetate and monensin; 2) melengestrol acetate, monensin and tylosin; 3) melengestrol acetate, monensin and ractopamine; 4) melengestrol acetate, monensin, tylosin and ractopamine; 5) melengestrol acetate, monensin and zilpaterol and 6) melengestrol acetate, monensin, tylosin and zilpaterol combinations in Type C Medicated Feeds are approved as SAFE and EFFECTIVE – these combination approvals are for use in Type C Medicated Feeds combined for feeding on the farm or in the feedlot.       

Zoetis is currently working to resolve the situation and implementing the steps to submit the appropriate information to the US Food and Drug Administration - Center for Veterinary Medicine (CVM) to obtain the approval of Type B Medicated Feed Blue Bird labels which will allow the manufacture and sale of Type B Medicated Feeds containing:  1) melengesterol acetate and monensin and 2) melengestrol acetate, monensin and tylosin.  This process is anticipated to take 12-18 months before the situation is fully resolved.