2012年12月29日讯 --阿拉宾度(Aurobindo)宣布,萘夫西林注射液(nafcillin injections)获得了FDA的批准。萘夫西林是一种半合成青霉素,用于治疗由产青霉素酶葡萄球菌引发的感染。该公司已即刻启动了药物的装运。
英文原文:
US FDA approves Aurobindo Pharma's nafcillin injections
Aurobindo Pharma has secured approval from the US FDA to manufacture and market nafcillin for injection USP, packed in 1g and 2g bottles as well as nafcillin for injection USP 10g bottle pharmacy bulk package.
Nafcillin, is a sterile semisynthetic penicillin to treat infections caused by penicillinase producing staphylococci, which have shown susceptibility to the drug.
The injection may also be used for treatment in doubtful cases of resistant staphylococcal infections before receiving the susceptibility test results.
The USFDA approved nafcillin injections have been manufactured in unit XII formulation facility, Hyderabad, India, which will be marketed and sold by Aurobindo's US subsidiary AuroMedics Pharma.
The approved products are ready for launch,according to the company.
Aurobindo presently has 171 ANDA approvals, which include 145 final approvals and 26 tentative approvals from USFDA.
Out of the total 145 approvals, two approvals come from US-based Aurolife Pharma, part of Aurobindo group of companies.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients for six areas, which include antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals and anti-allergics.