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1549 News Found

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
Drug Approval | February 20, 2023

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States


USFDA accepts for priority review the sNDA for Merck’s Prevymis
Drug Approval | February 18, 2023

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients


Pfizer announces Talzenna and Xtandi combination data from phase 3 study
News | February 18, 2023

Pfizer announces Talzenna and Xtandi combination data from phase 3 study

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI


Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg
Drug Approval | February 18, 2023

Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg

Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)


Lupin receives EIR from USFDA for injectable facility in Nagpur
News | February 18, 2023

Lupin receives EIR from USFDA for injectable facility in Nagpur

The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022


Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Drug Approval | February 18, 2023

Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million


Briefs: Piramal Pharma, Alembic Pharmaceuticals
News | February 17, 2023

Briefs: Piramal Pharma, Alembic Pharmaceuticals

USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA


Shilpa Medicare Unit VI Bengaluru facility registered with Ministry of Health, UAE
News | February 17, 2023

Shilpa Medicare Unit VI Bengaluru facility registered with Ministry of Health, UAE

This registration enables companies to register the products (Orodispersible films and Transdermal systems) in UAE for commercialization


Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension
Drug Approval | February 16, 2023

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)


Zydus receives tentative approval from the USFDA for Canagliflozin tablets
Drug Approval | February 16, 2023

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya