Shilpa Medicare gets Import Alert from USFDA EP News Bureau Feb 19, 2021 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 EP News Bureau Feb 18, 2021 Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia
Lupin, Aurobindo recall drugs in US market Press Trust of India Feb 15, 2021 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 EP News Bureau Feb 12, 2021 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 EP News Bureau Feb 8, 2021 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… EP News Bureau Jan 28, 2021 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 EP News Bureau Jan 27, 2021 They are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy
Strides get USFDA nod for Ursodiol capsules EP News Bureau Jan 25, 2021 Ursodiol capsules are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC)
Zydus Cadila gets US FDA nod for Liothyronine Sodium Tablets EP News Bureau Jan 24, 2021 It is a man-made form of thyroid hormone which is used to treat an underactive thyroid (hypothyroidism)
Strides gets USFDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets EP News Bureau Jan 15, 2021 The combination of Emtricitabine and Tenofovir slows down the spread of HIV in the body and is used along with other medications…