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Monday, May 12, 2014

Actions Taken by FDA Center for Veterinary Medicine The following corrections or additions to the list were published in the Federal Register in April 2014.

Actions Taken by FDA Center for Veterinary Medicine
The following corrections or additions to the list were published in the Federal Register in April 2014.

Original Approvals
April, 2014 CVMGreenBookandAnimalDrug@fda.hhs.gov 1
This section displays the original approval. To read the complete approval, please refer to 21CFR Parts 500 and the related Federal Register notices.


NADA Number: 141-361
 Trade Name: Pulmotil® AC 
 Ingredients: Tilmicosin phosphate
 Sponsor: Elanco Animal Health a Division of Eli Lilly & Co.
 Approval Date: February 13, 2014
 Status: Rx
 Route: Oral, in drinking water
 Species: Swine
 Drug Form: Aqueous concentrate
 Concentration: 250 mg tilmicosin/mL
Indications: For the control of swine respiratory disease associated with Pasteurella
multocida and Haemophilus parasuis in groups of swine in buildings where a
respiratory disease outbreak is diagnosed.
Exclusivity: 3 years


 21 CFR 522.2471 79 FR 18156
NADA Number: 141-420
 Trade Name: Tildren®
 Ingredients: Tiludronate disodium
 Sponsor: Ceva Sante Animale
 Approval Date: February 13, 2014
 Status: Rx
 Route: Intravenous infusion
 Species: Horse
 Drug Form: Powder for injection
 Concentration: 500 mg tiludronate disodium
Indications: For the control of clinical signs associated with navicular syndrome in horses.
Exclusivity: 5 years


 21 CFR 516.2473 79 FR 18156
NADA Number: 141-422
 Trade Name: Paccal Vet®-CA1 
 Ingredients: Paclitaxel
 Sponsor: Oasmia Pharmaceutical AB
 Approval Date: February 27, 2014
 Status: Rx
 Route: Intravenous injection
 Species: Dog
 Drug Form: Powder for injection
 Concentration: Each milliliter of constituted solution contains 1 mg paclitaxel
Indications: For the treatment of nonresectable stage III, IV or V mammary carcinoma in
dogs that have not received previous chemotherapy or radiotherapy. For the
treatment of resectable and nonresectable squamous cell carcinoma in dogs
that have not received previous chemotherapy or radiotherapy.
Exclusivity: 7 years

 Patent: Patent Number Expiration date:
 6,642,271 March 15, 2022
 7,030,158 November 15, 2022
 12/809,259 December 18, 2028
 21 CFR 516.1684 79 FR 18156

http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/UCM396609.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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