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- Caplin Steriles Limited received final FDA approval for its generic Desmopressin Acetate Injection USP, covering both single-dose and multiple-dose vials for treating bleeding disorders and diabetes insipidus. - The approved product is a therapeutic equivalent to Nordic Pharma's DDAVP injection and enters a market worth approximately $26 million in annual U.S. sales according to IQVIA data. - This approval represents the 52nd ANDA approval for parent company Caplin Point Laboratories, strengthening its position in the U.S. injectable pharmaceutical market.
- Caplin Steriles, a subsidiary of Caplin Point Laboratories, has received final USFDA approval for its generic version of Haloperidol Decanoate Injection, used for treating schizophrenia patients requiring long-term antipsychotic therapy. - The approved product comes in multiple formulations including 50mg/mL and 100mg/mL single-dose vials and 500mg/5mL multiple-dose vials, equivalent to Janssen Pharmaceuticals' HALDOL injection. - According to IQVIA data, Haloperidol Decanoate Injection generated approximately $16.4 million in US sales for the 12-month period ending March 2025, representing a significant market opportunity.
• Zhaoke Ophthalmology's TAB014 met primary and key secondary endpoints in a Phase 3 trial for wet age-related macular degeneration (AMD). • Caplin Steriles received FDA approval for its generic difluprednate ophthalmic emulsion, used to treat inflammation and pain after ocular surgery. • Valo Health will seek a partner for OPL-0401, a diabetic retinopathy drug, after it failed to meet endpoints in the SPECTRA trial. • GEMMABio secured $34 million in seed funding to advance its gene therapy programs, focusing on rare diseases in Brazil.
• Caplin Steriles has received FDA approval for its generic version of difluprednate ophthalmic emulsion, 0.05%, a therapeutic equivalent to DUREZOL. • The approval allows Caplin Steriles to market a more affordable alternative for treating inflammation and pain associated with ocular surgery. • This generic medication mirrors Sandoz Inc.'s DUREZOL, offering similar efficacy and safety profiles for patients requiring corticosteroid treatment in the eye. • The FDA's decision underscores Caplin Steriles' commitment to providing accessible and cost-effective pharmaceutical options in the ophthalmology space.
