FDA Approvals | Peptide

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
gramicidin1968 - 200507Peptide
sincalideBracco1976 - 20221976 - 202220Peptide
oxytocinNovartis1980 - 20181980 - 198563Peptide
octreotideNovartis1988 - 20251988 - 2024423Peptide
in111-octreoscanCurium Pharma1994 - 2024199411Peptide
glatiramer acetateTeva1996 - 20261996110Peptide
eptifibatideMerck1998 - 20241998115Peptide
lepirudinBayer1998199810Peptide
technetium tc-99m apcitideCIS Bio International S.A.1998199810Peptide
ganirelixOrganon1999 - 2025199917Peptide
tc-99m depreotideCIS Bio International S.A.1999199910Peptide
triptorelinVerity Pharmaceuticals2000 - 20172000 - 201740Peptide
nesiritideScios2001200110Peptide
secretin humanChiRhoClin, Inc.2002 - 20042002 - 200430Peptide
teriparatideEli Lilly2002 - 20252002 - 202443Peptide
enfuvirtideRoche2003200310Peptide
ziconotideTersera Theraps Llc2004200410Peptide
exenatideAstraZeneca2005 - 20242005 - 201741Peptide
pramlintideAstraZeneca2005200510Peptide
lanreotideIpsen2007 - 20242007 - 202121Peptide
49 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