Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
Ursodeoxycholic acid or ursodiol is a naturally occurring bile acid that is used dissolve cholesterol gall stones
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
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 drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
Decision on EU marketing authorisation for this population expected by September 2024
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The product is bioequivalent and therapeutically equivalent to the reference listed drug
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
The inspections concluded with no Form 483 observations or significant critical findings
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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