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Results For "approval"

2475 News Found

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi
Drug Approval | February 28, 2023

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region


Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg
Drug Approval | February 27, 2023

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.


Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData
Drug Approval | February 27, 2023

Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData

The British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country


Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


Venus Remedies gets marketing approval for cancer drugs from Uzbekistan, Palestine
News | February 23, 2023

Venus Remedies gets marketing approval for cancer drugs from Uzbekistan, Palestine

The marketing authorisations for three generic drugs signifying advances in cancer treatment will considerably benefit thousands of patients by improving access, ensuring affordability


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


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)


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


Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing
Drug Approval | February 18, 2023

Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing

Themis will market this drug with the brand name REMITHEM.