FDA Approvals | Biological

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
mixed vespid venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
wasp venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
yellow hornet venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
yellow jacket venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
albumin (Human)Grifols1942 - 20181942 - 2018110Biological
immune globulin (human)Grifols1944 - 20251944 - 2025230Biological
corticotropinSanofi-Aventis1950 - 20121950 - 201093Biological
thyrotropinSanofi-Aventis1953195310Biological
tetanus immunoglobulinGrifols1957195710Biological
Plasma Protein Fraction (Human)Grifols1958195810Biological
chymotrypsinJohnson and Johnson1959 - 19791959 - 197940Biological
glucagonEli Lilly1960 - 20251960 - 201966Biological
fibrinolysin, humanPfizer1964196410Biological
collagenase clostridium histolyticumSmith & Nephew1965 - 20201965 - 202030Biological
intrinsic factorMallinckrodt1968 - 19711968 - 197130Biological
human factor ix complex (prothrombin complex concentrate)Baxalta1970 - 20231970 - 202340Biological
Rho(D) Immune Globulin Intravenous (Human)Grifols1971 - 20041971 - 200440Biological
human choriogonadotropin alfaFresenius1973 - 20001973 - 200075Biological
antihemophilic factor viii humanGrifols1974 - 20101974 - 201060Biological
rabies immune globulin (human)Grifols1974 - 20171974 - 201730Biological
69 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