The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The capsules are the generic version of the reference listed drug Mycobutin
It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation
Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune
FDA changes inspection classification of the facility to Voluntary Action Indicated
The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.
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