Wockhardt gets tentative approval for generic levofloxacin pills (Levaquin) in US

Indian generic firm Wockhardt has received tentative approval to market levofloxacin tablets from US FDA.

Wockhardt’s levofloxacin is the generic equivalent of the brand Levaquin, marketed in the US by Ortho Mcneil (Johnson & Johnson).

Levofloxacin, which belongs to the fluoroquinolone group of antibiotics, is used for treatment in a broad spectrum of bacterial infections.

The total market for levofloxacin tablets in the US is about $1.6 billion, according to the IMS.

The United States Food & Drug Administration has given its approval for marketing levofloxacin tablets in the strengths of 250mg, 500mg and 750mg, Wockhardt Ltd said in a statement.

Wockhardt is planning to launch its generic version of levofloxacin immediately upon expiration of the patent on June 20, 2011.

Wockhardt will manufacture levofloxacin tablets at the US FDA certified formulation plant at Waluj, Aurangabad.

Last week, Wockhardt received tentative approval for generic memantine for treatment of Alzheimer’s disease from US FDA.

Wockhardt received conditional marketing approvals the 5mg and 10mg tablets of memantine HCl, Wockhardt said in a press release.

Wockhardt’s memantine is a therapeutic equivalent of the brand Namenda, marketed in the United States by Forest Laboratories.

Memantine is used for treatment of moderate to severe Alzheimer’s disease and dementia.

Forest’s patents covering Namenda (memantine) is under litigation in the US courts.

The total market for memantine tablets in the US is about $1.1 billion and is the first in a novel class of Alzheimer’s drugs that block NMDA glutamate receptors, according to IMS Health.

Wockhardt and Forest Laboratories have reached a settlement on their patent litigation, which will allow Wockhardt to launch its generic version several months ahead of patent expiration o