Cadila receives USFDA approval for marketing hypertension drug
Zydus Pharmaceuticals (USA) Inc, a wholly owned subsidiary of Cadila Healthcare, has got final approval from the US Food and Drug Administration to market Nifedipine extended...
Tag : USFDA
Morepen Lab receives USFDA clearance for Montelukast Sodium
Morepen Laboratories has received USFDA clearance for its bulk drug Montelukast Sodium. The company stated, “This gives Morepen an entry into the Rs.2,000 crore (approximately...
Lupin receives approval for Tydemy from USFDA
Lupin has received approval from the US health regulator, for Tydemy drug that is used to prevent pregnancy. The company has received final approval for its Tydemy (Drospirenone, Ethinyl...
Orchid Pharma receives approval for schizophrenia drug from USFDA
Orchid Pharma receives approval for Aripiprazole Orally-Disintegrating tablets from the US health regulator. The company in a filing to BSE stated it, “has received ANDA (abbreviated...
J B Chemicals & Pharma gets USFDA approval for hypertension tablets
J B Chemicals & Pharmaceuticals receives approval from US health regulator for Atenolol tablets, which is used for treating high blood pressure. In a BSE...
Alembic Pharma gets approval from USFDA for bladder drug
Alembic Pharmaceuticals has received approval from the US Food and Drug Administration, to treat overreactive bladder with symptoms of urinary incontinence, urgency and frequency. In...
Dr Reddy’s receives EIR for Bachupally unit from USFDA
Dr Reddy’s Laboratories has received an establishment inspection report (EIR) for Bachupally unit, Hyderabad, after the closure of its audit from the US Food and Drug...
Cadila receives USFDA approval for drug that treats schizophrenia
Cadila Healthcare’s subsidiary, has received approval from the US health regulator for Clozapine tablets, which is used to treat schizophrenia. In a filing the company stated,...
Dr Reddy’s receives EIR for Telangana unit, from USFDA
Dr Reddy’s Laboratories has received Establishment Inspection Report (EIR), for its Miyapur facility, Hyderabad, Telangana. The Custom Pharmaceutical Services facility, of Dr Reddy’s Laboratories at the...
Biocon, Mylan receives approval for biosimilar version of Herceptin
USFDA has given approval to Mylan’s Ogivri, which is a biosimilar of cancer drug Herceptin, co-developed with Biocon. Trastuzumab is the generic name of Herceptin. Ogivri has received...