Hospira’s generic antibiotic Meropenem approved in US

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Hospira’s generic antibiotic Meropenem approved in US

Genéricos/Novedades | Posted 09/07/2010 0 Post your comment

On 22 June 2010, Hospira announced that it had received approval from the FDA for its generic antibiotic, Meropenem. This is the first generic launched in the antibiotic class and Hospira is the first to market.

The medication, a carbapenem that belongs to the beta-lactam class of antibiotics, is a generic version of AstraZeneca's Merrem (meropenem). Sales of the brand name product in the US were approximately US$200 million in 2009.

Meropenem is used in moderate to severe bacterial infections in patients who (in most cases) have been admitted to hospital. These infections include pneumonia, abdominal infections, septicaemia, lung infections, bacterial meningitis, skin infections and bladder, kidney and womb infections.

US-based generics manufacturer, Hospira, is one of the world leaders in specialty generic injectable pharmaceuticals, and expects the introduction of Meropenem in the US to “propel Hospira to a position of leadership in this category of antibiotics".

"This is the first generic carbapenem approved in the US” said President, Hospira, US, Mr Thomas Moore, adding that "Hospira is committed to continuing to reduce the cost of healthcare spending by providing savings with first-to-market generic launches".

Meropenem represents the first US drug launch from Hospira's recent acquisition of the generic injectables business, Orchid Chemicals & Pharmaceuticals. Beta-lactam antibiotics represent a class of drugs with a wide spectrum of antibacterial activity. The US market value of beta-lactam molecules is more than US$1 billion, based on 2009 sales, according to IMS Health.

Hospira currently has around 200 generic injectable drugs on its books in many different dosages and formulations. In addition, many of its products are available in popular differentiated presentations, several of which are proprietary, such as the ADD-Vantage drug delivery system and iSecure prefilled syringes. Hospira also has robust pipelines of both generic and biosimilar drugs.

Reference:

Hospira News Release, Hospira Receives FDA Approval for Meropenem for Injection, USP (I.V.), 22 June 2010