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Browsing Tag
USFDA
Zydus Cadila gets final nod from USFDA for Droxidopa Capsules
It is indicated for use in people with conditions of the nervous system that can cause low blood pressure
Unichem Laboratories gets USFDA approval for Apremilast Tablets
Apremilast tablets are indicated for the treatment of plaque psoriasis
Shilpa Medicare gets Import Alert from USFDA
Three products have been exempted from the Import Alert - Azacitidine for Injection, Cyclophosphamide Capsules and Erlotinib…
Dr Reddy’s launch Fluphenazine Hydrochloride Tablets in US
Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia
Lupin, Aurobindo recall drugs in US market
Lupin Pharma is recalling 46,479 bottles of Oseltamivir Phosphate for Oral Suspension while AuroMedics Pharma, a unit of Aurobindo…
Strides gets USFDA approval for Prednisone Tablets
Prednisone is a corticosteroid used as an anti-inflammatory or an immunosuppressant medication to treat different conditions such…
US FDA makes five observations after Alembic Pharma facility inspection
Alembic Pharma informed that “none of the observations are related to data integrity and are procedural in nature”
US FDA grants Orphan Drug Designation to Zydus’ Saroglitazar for primary biliary cholangitis…
This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020
Unichem gets USFDA approval for Zonisamide Capsules
They are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy