Regulatory | 11 August 2024
Caplin Point announces completion of unannounced USFDA inspection
The inspection was concluded with zero observations
The inspection was concluded with zero observations
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
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
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