Drug Approval | 30 November 2022
AstraZeneca’s Dapagliflozin receives CDSCO approval
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The company had responded to the agency and carried out the required corrective actions.
The product is expected to be launched by Q4 FY23.
The approval further strengthens the Potassium Chloride franchise for the company.
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
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