Aurobindo Pharma's antibiotic ANDA gets Canadian approval
03 Mar 2010
Hyderabad-based Aurobindo Pharma Ltd. has received Health Canada's approval for its abbreviated new drug application (ANDA) Cefuroxmine Axetil tablets 250mg and 500 mg, the company said in a statement today.
This is Aurobiondo's eighth approval from Health Canada.
These tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated micro organisms and falls under the antibiotic segment.
Cefuroxmine Axetil tablets are the generic equivalent of GlaxoSmithKline Canada`s Ceftin tablets 250mg and 500 mg.
Last week, the company received the tentative approval to manufacture and market Nevirapine tablets for Oral Suspension 50mg (NDA) from the US Food & Drug Administration (FDA). It has a total of 113 ANDA approvals (84 final approvals and 29 tentative approvals) from the US FDA.
In December last year, Aurobindo Pharma Australia Pty Ltd, a wholly owned subsidiary of Aurobindo Pharma, had received approval from Australia's Therapeutic Goods Administration (TGA), for the registration of citalopram hydrobromide tablets, 10mg, 20mg and 40mg.
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