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3217 News Found

Zydus receives final approval from USFDA for Lubiprostone Capsules, 8 mcg and 24 mcg
Drug Approval | March 25, 2023

Zydus receives final approval from USFDA for Lubiprostone Capsules, 8 mcg and 24 mcg

Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation)


Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets
Drug Approval | March 24, 2023

Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).


PM chairs high-level meeting to asses situation of Covid-19 & Influenza
Policy | March 23, 2023

PM chairs high-level meeting to asses situation of Covid-19 & Influenza

PM emphasises the need to enhance lab surveillance & testing of all Severe Acute Respiratory Illness (SARI) cases & ramp up genome sequencing


Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Drug Approval | March 22, 2023

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)


Granules Consumer Health concludes FDA audit with zero observations
Drug Approval | March 22, 2023

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility


Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets
Drug Approval | March 21, 2023

Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


Patritumab Deruxtecan shows better clinical activity in patient with lung and breast cancer
Diagnostic Center | March 20, 2023

Patritumab Deruxtecan shows better clinical activity in patient with lung and breast cancer

Subgroup analysis by HER2 expression from phase 1/2 trial of patients with HER3 expressing metastatic breast cancer highlighted in a second Presidential Session


Janssen announces novel dengue antiviral demonstrates efficacy in pre-clinical data
News | March 20, 2023

Janssen announces novel dengue antiviral demonstrates efficacy in pre-clinical data

The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans