Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) reported on Monday the receipt of the Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for generic TobraDex (tobramycin/dexamethasone) in 0.3%/0.1% for treating bacterial ocular infection.
With the approval of TobraDex (tobramycin/dexamethasone) in 0.3%/0.1%, the company said it adds another complex ophthalmic product to its generics portfolio.
TobraDex is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists, added the company.
US annual sales for dexamethasone and tobramycin ophthalmic suspension, including the brand TobraDex, for the 12 months ended May 2021 were approximately USD118m, as reported by IQVIA.
Chemomab secures new patents for CM-101 monoclonal antibody
argenx receives FDA priority review for VYVGART Hytrulo in CIDP
AffaMed Therapeutics' DEXTENZA NDA accepted by Singapore regulator
AbbVie showcases gastroenterology portfolio at ECCO Congress
Japan approves Sanofi's Dupixent for chronic spontaneous urticaria
Ono partners with Shattuck Labs for bifunctional fusion proteins
Zymedi commences first in human dosage of ZMA001
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
EicOsis Human Health commences EC5026 Phase 1b multiple-ascending dose clinical trial
Takeda's HyQvia approved for maintenance therapy in CIDP patients
Celltrion USA submits CT-P47 Biologics License Application to FDA
Formosa Pharmaceuticals agrees licensing deal in Brazil for APP13007