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USFDA issues Form 483 to an Aurobindo Pharma subsidiary with one observation
After inspecting a facility owned by its US-based unit, Aurobindo Pharma reported that the US health regulator had made one observation. The Pre-Approval Inspection and GMP inspections by the USFDA were carried out at the Raleigh based plant from August 22–26.
Chlorthalidone Tablets USP, 25 mg and 50 mg, approved by USFDA
Alembic Pharmaceuticals Limited announced that its Abbreviated New Drug Application (ANDA) for Chlorthalidone Tablets USP, 25 mg and 50 mg had been given final approval by the US Food & Drug Administration.
Lupin receives USFDA approval for its generic cancer drugs
Lupin announced that it has received a provisional approval from the US health regulator to market Dasatinib tablets-used to treat specific types of cancer-in the US in dose levels of 20, 50, 70, 80, 100, and 140 mg.
Scemblix from Novartis approved in Europe to treat adult patients with chronic myeloid leukaemia
The European Commission (EC) has authorised Scemblix (asciminib) for the treatment of adult patients with chronic myeloid leukaemia that is in the chronic phase and has the Philadelphia chromosome.
Govt might lower TMR on 139 drug formulations in first phase
The government has identified 139 formulations, including medications like Remdesivir, influenza medications, Tocilizumab, some patented drugs, among others, and plans to implement trade margin rationalization in stages.
Competitive Profile of Kerendia by Bayer in CKD Related to Type 2 Diabetes
Data from a Kerendia (finerenone) Phase III trial were released by Bayer, demonstrating the drug’s potential to lower the risk of cardiovascular and all-cause mortality in type 2 diabetes.
Drug Farxiga from AstraZeneca becomes first to reduce fatality across all forms of heart failure
Farxiga (dapagliflozin), a diabetes drug, is the
first heart failure (HF) medication to show
mortality benefits for all forms of HF, according
to a pre-specified pooled analysis from
AstraZeneca’s Phase III trial in patients with HF.
