Alembic Pharma arm gets USFDA nod for Treprostinil Injection Ruchika Sharma13 Feb 2021 3:29 PM ISTTreprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH;WHO Group 1) to diminish symptoms associated with...
Strides Pharma secures USFDA approval for Prednisone Tablets Ruchika Sharma12 Feb 2021 1:49 PM ISTBengaluru: Drug major, Strides Pharma Science Limited, announced that the company's step-down wholly owned subsidiary, Strides Pharma Global Pte....
Indian pharma firm told to pay Rs 363 crore fine for destroying records before USFDA inspection Ruchika Sharma11 Feb 2021 1:42 PM ISTAs a part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanour offense, pay a criminal fine of USD 30 million, and forfeit an...
Glenmark gets USFDA nod to Clindamycin Phosphate Gel to treat acne Ruchika Sharma11 Feb 2021 1:23 PM ISTMumbai: Drugmajor, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food &...
Alembic Pharma Gujarat facility gets 5 USFDA observations Ruchika Sharma10 Feb 2021 2:20 PM ISTNew Delhi: Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at...
Lupin gets USFDA nod for generic equivalent of Kerydin Topical Solution Ruchika Sharma10 Feb 2021 1:54 PM ISTMumbai, Baltimore: Global pharma major, Lupin Limited, has recently announced that the company has received approval for its Tavaborole Topical...
Rhizen Pharma gets USFDA accelerated nod for Partnered asset Umbralisib adult patients with Relapsed or Refractory MZL & FL Ruchika Sharma9 Feb 2021 12:04 PM ISTBasel, Switzerland: Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, has recently announced that the company's...
Novartis gets USFDA Breakthrough Therapy designations for STAMP inhibitor asciminib to treat chronic myeloid leukemia Ruchika Sharma9 Feb 2021 11:00 AM ISTAsciminib (ABL001) is an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP).
Sun Pharma recalls 36,275 cartons of Testosterone Cypionate Injection in US over incorrect labelling Ruchika Sharma8 Feb 2021 11:26 AM ISTElaborating on the reasons for the Class III recall, the USFDA said: "Incorrect Labelling: Incorrect lot number on secondary packaging."
Glenmark Pharma bags USFDA nod for Topiramate Extended-Release Capsules Ruchika Sharma4 Feb 2021 12:21 PM ISTMumbai: Drug major, Glenmark Pharmaceuticals Limited, has recently announced that the company has received final approval by the United States...
Dr. Reddys unveils Vigabatrin Tablets to treat complex partial seizures in US Ruchika Sharma3 Feb 2021 12:14 PM ISTHyderabad and Princeton: Drug major, Dr. Reddy's Laboratories Ltd., has recently announced the launch of Vigabatrin Tablets USP, 500 mg in the...
Zydus erectile dysfunction drug Avanafil to be sold only on Cardiologists, Psychiatrists, Urologists prescription: CDSCO panel Farhat Nasim1 Feb 2021 6:39 PM ISTNew Delhi: Noting that Avanafil Tablets should be sold by retail on the prescription of Cardiologists, Psychiatrists and Urologists only, the...
