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Teva authorised to market generic version of contraceptive
03 Apr 2009
Regulatory Affairs
The US Food and Drug Administration (FDA) has granted approval for Teva to market a generic version of Bayer Healthcare Pharmaceuticals' oral contraceptive.
Its abbreviated new drug application has been authorised by the regulatory body, granting the Israeli company a 180-day period of marketing exclusivity for the tablets as it was the first firm to file a paragraph four certification for the product.
Teva's subsidiary, Barr Pharmaceuticals, signed a deal with Bayer last year, gaining the right to launched an authorised generic version of the drug, Yaz, on July 1st, 2011, or earlier under certain circumstances.
It reports that annual sales of the contraceptive amounted to around $616 million (£416 million) in the US last year.
The approval is the latest in a series of similar authorisations, in which Teva has been given the go-ahead to market its generic forms of drugs from leading pharmaceutical firms.
Last month, the FDA authorised its versions of Ortho-McNeil's anticonvulsant, Topamax and GlaxoSmithKline's migraine treatment, Imitrex.
