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3155 News Found

Lupin receives USFDA approval for Brivaracetam Tablets
Drug Approval | December 23, 2022

Lupin receives USFDA approval for Brivaracetam Tablets


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules
Drug Approval | December 23, 2022

Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules

Pregabalin Capsules have an estimated market size of US $244 million for twelve months ending Sep 2022 according to IQVIA


Glenmark launches Triple FDC of Teneligliptin with Pioglitazone and Metformin for adults with Type 2 Diabetes
News | December 22, 2022

Glenmark launches Triple FDC of Teneligliptin with Pioglitazone and Metformin for adults with Type 2 Diabetes

This FDC has been launched under the brand name Zita-PioMet, and contains Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) in a sustained release (SR) formulation


Vaishali Pharma signs partnership agreement with Jark Pharma
News | December 22, 2022

Vaishali Pharma signs partnership agreement with Jark Pharma

As per the agreement, NSE-listed Vaishali Pharma Limited will take over the entire domestic and international marketing of Jark Pharma’s portfolio of quality based ayurvedic products


Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer
Drug Approval | December 20, 2022

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting


Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules
Drug Approval | December 20, 2022

Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million


USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
Drug Approval | December 20, 2022

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

None of the observations are related to data integrity and management believes that they are addressable