Drug Approval | July 10, 2024
Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
The approved ANDA is therapeutically equivalent to the reference listed drug product
The approved ANDA is therapeutically equivalent to the reference listed drug product
Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025
Imfinzi also recommended for patients with mismatch repair deficient disease
Laurus Labs receives EIR from USFDA for API facilities
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
This tie-up will have no impact on any other brands of the company
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
DSP-5336, an Investigational Menin and Mixed-lineage Leukemia Inhibitor, is Being Evaluated in Patients with Relapsed or Refractory Acute Leukemia
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