Zydus gets USFDA approval for anti-obsessional drug
Cadila Healthcare’s US subsidiary has received approval for anti-obsessional drug, from the US health regulator. In a filing the company stated that, Zydus Pharmaceuticalst (USA) Inc,...
Tag : USFDA
Lupin gets USFDA nod for Calcipotriene Topical Solution
Lupin has received final approval for Calcipotriene Topical Solution, 0.005% (Scalp Solution), from USFDA. The company has received approval to market a generic version of Dovonex...
Dr Reddy’s receives USFDA approval for Sapropterin Dihydrochloride
Dr Reddy’s Laboratories has received approval from the US health regulator for drug that reduces blood phenylalanine concentrations in patients. It has received tentative approval from...
Aurobindo receives USFDA approval for Fondaparinux Sodium injection
The US health regulator has given approval to Aurobindo Pharma, for manufacturing and marketing generic version of Fondaparinux Sodium injection, which is used to prevent deep vein...
Glenmark receives USFDA approval for generic version of Minastrin tablet
The US health regulator has given final approval to Glenmark Pharmaceuticals for a generic version of Minastrin 24 tablets, which is used to prevent pregnancy....
Sun Pharma receives USFDA acceptance for new drug application
The US health regulator has accepted a new drug application (NDA) for an ophthalmic solution, which was filed by Sun Pharma’s wholly owned subsidiary. In...
Alembic’s associate company receives USFDA approval for cancer drug
Alembic Pharmaceuticals associate company Rhizen Pharmaceuticals has received approval from USFDA for cancer drug. According to a BSE release, “Rhizen Pharmaceuticals S.A. today announced that...
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...
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...