Generic pharmaceutical company DifGen Pharmaceuticals announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for Fluorometholone Ophthalmic Suspension, 0.1%, a complex generic formulation used to treat eye inflammation.
This is only the second generic FDA approval of this complex suspension product, DifGen said.
Fluorometholone Ophthalmic Suspension is a corticosteroid indicated for treating steroid-responsive inflammatory conditions of the eye's anterior segment.
Ramandeep Singh Jaj and Santhanakrishnan Srinivasan, DifGen Pharmaceuticals founders and co-CEO's, said: "We are extremely proud that we received this first cycle approval, which marks a significant milestone for DifGen, demonstrating our expertise in developing complex ophthalmic suspension products with a high regulatory threshold for demonstration of therapeutic equivalence."
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Physiomics secures new modelling contract with Numab Therapeutics
Simcere Pharmaceutical enter licence and collaboration agreement with Boehringer Ingelheim
Insilico Medicine's ISM8969 receives US FDA IND approval for Parkinson's Disease
LEO Pharma advances delgocitinib cream into phase 3 trial for lichen sclerosus
HistoIndex partners Houston Research Institute
Formosa Pharmaceuticals licenses APP13007 ophthalmic therapy to Samil for South Korea
Bambusa Therapeutics reports first patient dosed in proof-of-concept COPD trial
Elanco Animal Health's Befrena (tirnovetmab) receives USDA approval for canine dermatitis
Sanofi and Regeneron's Dupixent gains Japan approval for paediatric asthma patients aged 6 to 11
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA