[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Rules and Regulations]
[Pages 18125-18126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06689]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 526
[Docket No. FDA-2019-N-0002]
New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of eight new animal drug applications (NADAs) at the sponsor's request
because the products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective March 30, 2020
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug
[[Page 18126]]
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761,
[email protected].
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw
approval of the NADAs listed in the following table because the
products are no longer manufactured or marketed:
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File No. Product name 21 CFR section
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055-036...................... PRINCILLIN 520.90c.
(ampicillin
trihydrate) Capsules.
055-050...................... PRINCILLIN 520.90e.
(ampicillin
trihydrate) Soluble
Powder.
055-056...................... PRINCILLIN 520.90f.
(ampicillin
trihydrate) Bolus.
055-061...................... PRINCILLIN ``125'' 520.90d.
For Oral Suspension.
055-068...................... BOVICLOX (cloxacillin 526.464b.
benzathine).
065-013...................... Dihydrostreptomycin 522.650.
(dihydrostreptomycin
sulfate).
065-493...................... JETPEN (penicillin G 522.1696a.
benzathine and
penicillin G
procaine) Aqueous
Suspension.
065-500...................... TANDEM PEN 522.1696b.
(penicillin G
procaine).
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Therefore, under authority delegated to the Commissioner of Food
and Drugs and in accordance with Sec. 514.116 Notice of withdrawal of
approval of application (21 CFR 514.116), notice is given that approval
of NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 065-013, 065-493,
and 065-500, and all supplements and amendments thereto, is withdrawn,
effective March 30, 2020.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06689 Filed 3-30-20; 8:45 am]
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