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 Sodium for injection, 100 mcg/vial, 200 mcg/vial, ... Read More
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 and Drug Administration (FDA) as a one-time ... Read More
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 Food & Drug Administration (FDA). The approval ... Read More
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 Drug Administration (FDA) for the treatment of ... Read More
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 mg, 5 mg/6.25 mg, 10 mg/6.25 mg ... Read More
Lupin Limited gets FDA tentative approval for rosacea drug generic
India-based Lupin Limited said that it has obtained tentative approval for its abbreviated new drug application (ANDA) of Doxycycline Capsules, 40 mg from the US ... Read More
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 Administration (FDA) for its OTOF-GT gene therapy ... Read More
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) for its Moraiya formulations manufacturing plant near ... Read More
Lupin gets FDA tentative approval for generic of contraceptive pill
Lupin Limited has secured tentative approval for its Abbreviated New Drug Application (ANDA) for Drospirenone Tablets, 4 mg from the US Food and Drug Administration ... Read More
Alembic Pharmaceuticals gets FDA final approval for Ketorolac Tromethamine
Alembic Pharmaceuticals has secured final approval for its abbreviated new drug application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 ... Read More