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Home Industry News Schering-Plough announces “important” regulatory filings

Schering-Plough announces “important” regulatory filings

26th August 2009

Schering-Plough has announced two “important” regulatory filings with the European Medicines Agency (EMEA).

In a statement, the organisation explained that the EMEA has accepted for review the firm’s marketing authorisation application for a fixed-dose combination of formoterol fumarate and mometasone furoate for the management of asthma in patients over the age of 12.

Additionally, the EMEA has validated the company’s application for the combined oral contraceptive nomegestrol acetate (2.5 mg) / 17 beta-estradiol (1.5mg).

Commenting, Thomas Koestler, executive vice-president and president of the Schering-Plough Research Institute, said: “These two regulatory milestones are important steps toward advancing our late-stage pipeline and meeting patient needs.”

Marketing approval is also being sought for nomegestrol acetate/17 beta-estradiol.

He also asserted that the company, which introduced the over-the-counter antihistamine eye drop CLARITIN Eye earlier this month, is committed to offering a variety of different birth control options to women.

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