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Results For "FDA"

1767 News Found

Zydus receives final approval from USFDA for Doxepin Hydrochloride Capsules USP, 150 mg
Drug Approval | March 25, 2023

Zydus receives final approval from USFDA for Doxepin Hydrochloride Capsules USP, 150 mg

Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety


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).


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)


Zydus granted Orphan Drug Designation by USFDA for ZYIL1
Drug Approval | March 22, 2023

Zydus granted Orphan Drug Designation by USFDA for ZYIL1

ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates


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)


Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit
Drug Approval | March 19, 2023

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature


Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division
Drug Approval | March 13, 2023

Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

The company will be submitting the responses to US FDA observations within stipulated timeline