Drug Approval | August 20, 2024
Granules India receives ANDA approval for Glycopyrrolate Oral Solution
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The inspections concluded with no Form 483 observations or significant critical findings
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
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