[Federal Register Volume 63, Number 212 (Tuesday, November 3, 1998)]
[Rules and Regulations]
[Pages 59215-59216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29332]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
Implantation or Injectable Dosage Form New Animal Drugs;
Hyaluronate Sodium
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Anika Therapeutics, Inc. The supplemental
NADA provides for equine use of hyaluronate sodium injection containing
11 milligrams hyaluronate sodium per milliliter (mg/mL) rather than the
currently approved 10 mg/mL.
EFFECTIVE DATE: November 3, 1998.
FOR FURTHER INFORMATION CONTACT: Dennis M. Bensley, Jr., Center For
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-4105.
SUPPLEMENTARY INFORMATION: Anika Therapeutics, Inc., 236 West Cummings
Park, Woburn, MA 01810, formerly Anika Research, Inc., 160 New Boston
St., Woburn, MA 01801, filed supplemental NADA 122-578 that provides
for equine use of a 11-mg/mL Hyvisc (hyaluronate sodium) injection
instead of the currently approved 10-mg/mL injection. The injection is
for intra-articular use in horses for treatment of joint dysfunction
due to noninfectious synovitis associated with equine osteoarthritis.
The drug is limited to use by or on the order of a licensed
veterinarian. The supplemental NADA is approved as of September 30,
1998, and 21 CFR 522.1145 is amended in paragraph (a)(2) and by adding
paragraph (f) to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this supplemental
application may be seen in the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, except
Federal holidays.
In addition, the sponsor has changed its name and address. The
regulations are amended in 21 CFR 510.600(c) to
[[Page 59216]]
reflect the changes in sponsor name and address.
FDA has determined under 21 CFR 25.33(a)(1) that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) in the entry ``Anika Research, Inc.'' and in paragraph (c)(2) in
the entry ``060865'' by removing the sponsor name and address and
inserting in its place ``Anika Therapeutics Inc., 236 West Cummings
Park, Woburn, MA 01801''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
4. Section 522.1145 is amended by revising paragraph (a)(2) and
adding paragraph (f) to read as follows:
Sec. 522.1145 Hyaluronate sodium injection.
(a) * * *
(2) Sponsor. See 000009 in Sec. 510.600(c).
* * * * *
(f)(1) Specifications. Each milliliter of sterile aqueous solution
contains 11 milligrams of hyaluronate sodium.
(2) Sponsor. See 060865 in Sec. 510.600(c).
(3) Conditions of use--(i) Amount. Small and medium-size joints
(carpal, fetlock)--22 milligrams; larger joint (hock)--44 milligrams.
(ii) Indications for use. Treatment of joint dysfunction in horses
due to noninfectious synovitis associated with equine osteoarthritis.
(iii) Limitations. For intra-articular injection in horses only.
Treatment may be repeated at weekly intervals for a total of three
treatments. Not for use in horses intended for food. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
Dated: October 25, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-29332 Filed 11-2-98; 8:45 am]
BILLING CODE 4160-01-F11