Aurobindo gets USFDA nod for 3 generic antibiotic injections
Drug firm Aurobindo Pharma said it has received final approvals from the US health regulator to sell multiple strengths of its generic Ampicillin and Sulbactam for injections.
The company said the US Food and Drug Administration (USFDA) has approved its three Abbreviated New Drug Applications (ANDA) for Ampicillin and Sulbactam antibiotic injections, that are used for treatment of skin infections, abdominal and gynecological infections.
The approvals are for Ampicillin and Sulbactam for injection 1.5 g and 3.0 g (infusion bottles); Ampicillin and Sulbactam for injection 1.5 g and 3 g (single-use vials) and Ampicillin and Sulbactam for injection 15 g USP (Pharmacy Bulk Pack), it said in a statement.
The Ampicillin and Sulbactam for injection, falling under the anti-infective segment, is a generic equivalent to Pfizer's Reference Listed Drug Unasyn.
"The product has a market size of approximately $50 mn according to IMS as of June 2009 and is ready for launch," the company said.
With these approvals, the company's penicillin sterile injectable formulation facility in Hyderabad, now has 5 injectable products approved by USFDA.
Aurobindo has a total of 126 ANDA approvals (97 Final approvals and 29 Tentative approvals) from USFDA.
The shares of the company were trading at Rs 1064.90 per scrip in the afternoon trade on the Bombay Stock Exchange (BSE) up 1.65 per cent from its previous close.
Sep 30, 2010