Pyelonephritis
4 original drugs 4
Novel Drugs
5
Reformulations
0
Active Trials
2
Drug Targets
Clinical Pipeline by Phase
5 industry-sponsored trials across 3 sponsors
Novel Drugs by Company (New molecular entities)
Reformulations (5 drugs) Click to expand
Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.
Drug Targets
Generic Drugs (4 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs