Ranbaxy Laboratories today said it has failed to get the US health regulator's nod for launching generic version of Flomax, a prostrate drug, thereby missing the opportunity to launch the drug in America with exclusive marketing rights.
Aurobindo Pharma today said it has received a tentative approval from the US drug regulator for manufacturing and marketing of its Nevirapine tablets, used in the treatment of HIV infections.
The Centre for Drug Evaluation and Research (CDER), which as a US FDA agency monitors most drugs, has told Hyderabadbased Dr Reddy's that it needs more time to resolve the
Glenmark Generics announced that it will commence marketing and distribution of Ciclopirox Olamine cream (0.77 per cent) following the US FDA approval for its generic drug application.
Drug firm Aurobindo Pharma on Thursday said that it has received final approval from the US health regulator for Perindopril Erbumine Tablets, used for the treatment of hypertension.
Pharmaceutical firm Ranbaxy today said it is in talks with the US Food and Drug Administration (USFDA)to sort out issues related to generic drugs but the matter is likely to take long to resolve.
Orchid Chemicals & Pharmaceuticals today said it has received the US nod.
Orchid Chemicals & Pharmaceuticals today said it has received final USFDA nod.
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