Browsing Tag
US Food and Drug Administration
348 posts
Ferring Pharmaceuticals gets Rebyota FDA approval for recurring CDI
Rebyota FDA approval : Ferring Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for…
Zydus Lifesciences gets FDA tentative approval for Levothyroxine Sodium generic
Zydus Lifesciences (previously Cadila Healthcare), through its US subsidiary Zydus Pharmaceuticals (USA), has secured tentative approval for Levothyroxine…
CSL Behring gets Hemgenix FDA approval for hemophilia B
CSL Behring, a US-based biotechnology company, has received approval for its Hemgenix (etranacogene dezaparvovec-drlb) from the US Food…
Strides Pharma gets FDA approval for Potassium Chloride Oral Solution generic
Strides Pharma Science has secured approval for Potassium Chloride Oral Solution USP, 40 mEq/15mL (20%) from the US…
Sun Pharmaceutical gets SEZABY FDA approval for neonatal seizures
Sun Pharmaceutical Industries has secured approval for SEZABY (phenobarbital sodium powder for injection) from the US Food and…
Zydus Lifesciences gets FDA final approval for BP drug generic version
Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for Bisoprolol Fumarate and Hydrochlorothiazide tablets USP, 2.5 mg/6.25…
Lupin Limited secures US FDA tentative approval for generic version of rosacea drug Oracea
Lupin Limited gains US FDA tentative approval for generic Oracea, targeting the $215M rosacea drug market in the US.
Sensorion OTOF-GT gene therapy candidate gets FDA rare pediatric designation
Sensorion, a French biotechnology company, has received the rare pediatric disease designation from the US Food and Drug…
Zydus Lifesciences gets FDA EIR with VAI for Moraiya formulations plant
Zydus Lifesciences said that the US Food and Drug Administration (FDA) has issued an establishment inspection report (EIR)…
Lupin secures US FDA tentative approval for generic version of Slynd contraceptive tablets
Lupin wins US FDA tentative approval for generic drospirenone contraceptive, targeting a $141M US market. See how this move fits its women’s health strategy.