Wockhardt gets US FDA approval for marketing Ceftazidime injections

November 6, 2008 by vikas

Pharmaceutical and biotechnology major Wockhardt will be launching Ceftazidime injection in the United States. Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for marketing the injections Ceftazidime, which is used for treating various kinds of infections. Ceftazidime is also sold as brand Fortaz by Glaxo Smithkline.

About Ceftazidime
Ceftazidime (INN) (pronounced /s?f?tæz?di?m/, /k?f-/) is a third-generation cephalosporin antibiotic. Like other third-generation cephalosporins, it has broad spectrum activity against Gram-positive and Gram-negative bacteria. Unlike most third-generation agents, it is active against Pseudomonas aeruginosa, however it has weaker activity against Gram-positive microorganisms and is not used for such infections. Ceftazidime pentahydrate is marketed under various trade names including Fortum.

Clinical Use
Ceftazidime is usually reserved for the treatment of infections caused by Pseudomonas aeruginosa. It is also used in the empirical therapy of febrile neutropenia, in combination with other antibiotics. It is usually given IV or IM every 8–12 hours (2 - 3 times a day), with dosage varying by the indication, infection severity, and/or renal function of the recipient. It is also first line treatment for the rare tropical infection, melioidosis.

Chemistry
In addition to the syn-configuration of the imino side chain, compared to other third-generation cephalosporins, the more complex moiety (containing two methyl and a carboxylic acid group) confers extra stability to ?-lactamase enzymes produced by many Gram-negative bacteria. The extra stability to ?-lactamases increases the activity of ceftazidime against otherwise resistant Gram-negative organisms including Pseudomonas aeruginosa. The charged pyridinum moiety increases water-solubility.

About Wockhardt
Wockhardt is a global, pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalisation and biotechnology.

The Company has a market capitalisation of over US$ 1 billion and an annual turnover of US$ 650 million. Wockhardt’s pace of growth and momentum permeates every mindset, system and technology within the organisation.

Wockhardt today, is distinguished by a strong and growing presence in the world’s leading markets, with more than 65% of its revenue coming from Europe and the United States. Wockhardt’s market presence covers formulations, biopharmaceuticals, nutrition products, vaccines and active pharmaceutical ingredients (APIs).
The Company has its headquarters in India, and has 14 manufacturing plants in India, UK, Ireland, France and US Subsidiaries in US, UK, Ireland and France Marketing offices in Africa, Russia, Central and South East Asia.

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