FDA Approvals | Recombinant protein

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.

Top 5 innovator ingredients

Top 5 generic ingredients

Top 5 innovator sponsors

Top 5 generic sponsors

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
somatropinSerono1976 - 20081976 - 2008170Recombinant protein
insulin humanEli Lilly1982 - 20191982 - 2019250Recombinant protein
interferon alpha-2aRoche1986 - 20041986 - 200420Recombinant protein
interferon alpha-2bMerck1986 - 20081986 - 200840Recombinant protein
alteplaseGenentech1987198710Recombinant protein
epoetinAmgen1989 - 20181989 - 201820Recombinant protein
interferon alfa-n3Hemispherx Biopharma1989198910Recombinant protein
human coagulation factor ixGrifols1990 - 20001990 - 200020Recombinant protein
sargramostimAmgen1991 - 20151991 - 201530Recombinant protein
aldesleukinClinigen, Inc.1992199210Recombinant protein
algluceraseGenzyme1992199210Recombinant protein
antihemophilic factor viii (Recombinant)Takeda1992 - 20191992 - 2019110Recombinant protein
dornase alfaGenentech1993199310Recombinant protein
interferon beta-1bBayer1993 - 20091993 - 200920Recombinant protein
imigluceraseGenzyme1994 - 20101994 - 201020Recombinant protein
lutropin alphaOrganon1994 - 20141994 - 201442Recombinant protein
insulin lisproEli Lilly1996 - 20201996 - 2020110Recombinant protein
interferon beta-1aBiogen1996 - 20021996 - 200220Recombinant protein
reteplaseChiesi1996199610Recombinant protein
becaplerminSmith & Nephew1997199710Recombinant protein
102 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