FDA Approvals | Animal product

Products regulated by the Food and Drug Administration comprise 25% of American consumer spending. The approaches used to approve these products can be as varied and complex as the products themselves. Such differences are dictated by Federal law and FDA identifies and enforces the relative risks and benefits that the products pose to consumers. These results convey summaries of products approved by FDA, including information about their past history and present status. The information not only applies to New Molecular Entities, but includes FDA approval information pertaining to new ingredients, dosages, therapeutic uses and generic equivalents.

Note: these approvals are sourced from Drugs@FDA and Purple Book, and do not currently reflect older FDA approvals and/or other evidence of US marketing.

Active Ingredients

Active IngredientInnovator SponsorApproval YearsInnovator YearsInnovatorGenericType
bee venomJubilant Innovation Ltd.1924 - 19911924 - 199120Animal product
Antivenin (Latrodectus mactans) (Equine)Merck1936193610Animal product
conjugated equine estrogensAmerican Home Products1942 - 20251942 - 2013132Animal product
hyaluronidase (bovine)Baxter1950 - 20251950 - 202570Animal product
Insulin, bovineBristol-Myers Squibb1950 - 19871950 - 1987110Animal product
crotalidae antivenin polyvalent (equine)American Home Products1954195410Animal product
Insulin, porcineEli Lilly1966 - 19801966 - 198070Animal product
insulin, regular, beef-porkEli Lilly1966196620Animal product
protamine insulinEli Lilly1966 - 19811966 - 198180Animal product
Antivenin (Micrurus fulvius) (Equine Origin)American Home Products1967196710Animal product
sutilainsAbbott1969196910Animal product
calcitonin salmonSanofi-Aventis1978 - 20261978 - 2005511Animal product
chymopapainRainbow Medical1982 - 19841982 - 198420Animal product
digoxin immune fab (ovine)Wellcome Trust1986 - 20011986 - 200120Animal product
thrombin (bovine)GenTrac, Inc.1986 - 20171986 - 201750Animal product
pegademase-bovineLeadiant Biosciences, Inc.1990199010Animal product
corticorelin ovine triflutateFerring1996199610Animal product
lymphocyte immune globulin, anti-thymocyte globulin (equine)Pharmacia & Upjohn1996199610Animal product
Anti-thymocyte Globulin (Rabbit)Genzyme1999199910Animal product
poractant alfaChiesi1999199910Animal product
29 ingredients
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Approval Applications

Appl NoTypeApprovalSponsorActive IngredientsMarketing StatusClassPriority?Links

Submission class glossary

TYPE 1
New Molecular Entity
TYPE 2
New Active Ingredient
TYPE 3
New Dosage Form
TYPE 4
New Combination
TYPE 5
New Formulation or New Manufacturer
TYPE 6
New Indication (pre-2009)
TYPE 7
Drug Already Marketed without Approved NDA
TYPE 8
Partial Rx to OTC Switch
TYPE 9
New Indication or Claim (existing NDA)
TYPE 10
New Indication or Claim (additional NDA)
MEDGAS
Medical Gas