Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 18

Results For "FDA"

1710 News Found

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets
Drug Approval | July 10, 2024

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults


Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules
Drug Approval | July 10, 2024

Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis


Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets
Drug Approval | July 10, 2024

Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets

This product will be manufactured at Lupin’s Pithampur facility in India


Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection
Drug Approval | July 09, 2024

Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection

Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux


FDA approves Roche’s Vabysmo PFS for three leading causes of vision loss
News | July 06, 2024

FDA approves Roche’s Vabysmo PFS for three leading causes of vision loss

Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness


Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg
Drug Approval | June 29, 2024

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients


Jubilant Ingrevia receives EIR from USFDA for Unit-1 at Bharuch
Drug Approval | June 28, 2024

Jubilant Ingrevia receives EIR from USFDA for Unit-1 at Bharuch

This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative


Eugia SEZ’s injectable facility gets EIR from USFDA
Drug Approval | June 28, 2024

Eugia SEZ’s injectable facility gets EIR from USFDA

The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated


Shilpa Medicare Bio Analytical unit gets
Drug Approval | June 27, 2024

Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA

This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies