Browsing Tag
US Food and Drug Administration
333 posts
Zydus Lifesciences gets FDA final approvals for Silodosin and Pregabalin capsules
Zydus Lifesciences (formerly known as Cadila Healthcare) has secured final approvals from the US Food and Drug Administration…
FDA grants EUA for Omicron-adapted Covid-19 vaccine for children below five
Pfizer and BioNTech have received the US Food and Drug Administration (FDA) emergency use authorization (EUA) for their…
Alembic Pharmaceuticals gets FDA final approval for Desonide Cream, 0.05%
Alembic Pharmaceuticals has secured final approval for its abbreviated new drug application (ANDA) of Desonide Cream, 0.05% from…
Rigel Pharmaceuticals gets Rezlidhia FDA approval for AML
Rigel Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its Rezlidhia (olutasidenib) capsules…
Zydus Lifesciences gets FDA approval for Estradiol Transdermal System
Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day,…
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…