Atrial Flutter
1 original drugs 1
Novel Drugs
10
Reformulations
0
Active Trials
10
Drug Targets
Market Leaders
Clinical Pipeline by Phase
8 industry-sponsored trials across 7 sponsors
Novel Drugs by Company (New molecular entities)
Reformulations (10 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.
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
HQ SPCLT PHARMA
T5 2016
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
HQ SPCLT PHARMA
T5 2016
SOTYLIZE
AZURITY
T3 2014
TIKOSYN
Pfizer
T1 1999
CORVERT
Pfizer
T1 1995
BETAPACE
LEGACY PHARMA
T1 1992
VERELAN
AZURITY
T3 1990
BREVIBLOC
Baxter
T1 1986
BREVIBLOC IN PLASTIC CONTAINER
Baxter
T1 1986
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
Baxter
T1 1986
Drug Targets
Generic Drugs (7 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