OXY-TET 50TM Bio-Mycin® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

OXY-TET 50TM Bio-Mycin®

Active ingredient

Oxytetracycline

Application type

NADA

Sponsor

Cronus Pharma Specialities India Private Ltd.

Applications on record

1

First published

May 1, 2023

Adverse event reports

Source: openFDA VeDDRA

1,137

Reports mentioning this ingredient

January 8, 1988 – January 8, 2026

100

Classified serious

per reporter assessment

128

Lack of expected efficacy

resistance signal

35

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “OXYTETRACYCLINE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Death	313
Solution, Abnormal	185
Anaphylaxis	176
Injection site swelling	143
Color, Abnormal	108
Lack of efficacy (bacteria) - NOS	105
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	84
Dyspnoea	64
Hypersalivation	54
Unclassifiable adverse event	48
Recumbency	39
Injection site pain	33
Accidental exposure	33
Residues in milk	27
Vials, Leaking	25
Depression	24
Vials, Damaged	23
No sign	22
PR-LUNG(S), LESION(S)	21
Injection site abscess	21

Species affected

Source: openFDA VeDDRA

Cattle 636 Horse 42 Human 41 Dog 31 Goat 24 Cat 22 Pig 18 Sheep 12 Other 3 Camel 1 Buffalo 1 Alpaca 1

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient