§ 522.1077 Gonadorelin. ( a ) *Specifications.* Each milliliter (mL) of solution contains: ( 1 ) 43 micrograms (μg) of gonadorelin as gonadorelin acetate;
( 2 ) 100 μg of gonadorelin as gonadorelin acetate;
( 3 ) 50 μg of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 μg gonadorelin); or
( 4 ) 50 μg of gonadorelin as gonadorelin hydrochloride.
( b ) *Sponsors.* See sponsor numbers in § 510.600(c) of this chapter. ( 1 ) No. 000061 for use of the 43-μg/mL product described in paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.
( 2 ) No. 068504 for use of the 100-μg/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
( 3 ) Nos. 000010 and 061133 for use of the 50-μg/mL product described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) and (v) of this section.
( 4 ) No. 054771 for use of the 50-μg/mL product described in paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.
( c ) *Related tolerances.* See § 556.304 of this chapter.
( d ) *Special considerations.* ( 1 ) Concurrent luteolytic drug use is approved as follows: ( i ) Cloprostenol injection for use as in paragraph (e)(1)(iii) of this section as provided by No. 000061 in § 510.600(c) of this chapter.
( ii ) Cloprostenol injection for use as in paragraph (e)(1)(iv) of this section as provided by No. 068504 in § 510.600(c) of this chapter.
( iii ) Cloprostenol injection for use as in paragraph (e)(1)(v) of this section as provided by Nos. 000010 in § 510.600(c) of this chapter.
( iv ) Dinoprost injection for use as in paragraph (e)(1)(vi) of this section as provided by No. 054771 in § 510.600(c) of this chapter.
( 2 ) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( e ) *Conditions of use in cattle* — ( 1 ) *Indications for use and amounts.* ( i ) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 μg gonadorelin (No. 000061), or 100 μg gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 μg gonadorelin (as gonadorelin acetate; No. 068504) by intramuscular or intravenous injection.
( ii ) For the treatment of ovarian follicular cysts in cattle: Administer 100 μg gonadorelin hydrochloride by intramuscular injection.
( iii ) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in beef cows and lactating dairy cows: Administer to each cow 86 μg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 μg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 μg gonadorelin by intramuscular injection.
( iv ) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 μg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 μg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 μg gonadorelin by intramuscular injection.
( v ) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 μg gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 μg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 μg gonadorelin diacetate tetrahydrate by intramuscular injection.
( vi ) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 100 to 200 μg gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 μg gonadorelin by intramuscular injection.
( 2 ) [Reserved]
[83 FR 64740, Dec. 18, 2018, as amended at 84 FR 8973, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019; 84 FR 32992, July 11, 2019; 86 FR 13184, Mar. 8, 2021; 86 FR 14820, Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 88 FR 27699, May 3, 2023]