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news.Mylan’s subsidiary Mylan Pharmaceuticals, a developer, manufacturer, marketer and distributor of generic pharmaceutical products in a variety of dosage forms, has launched Temazepam capsules of 7.5mg strength. Temazepam is indicated for the short-term treatment of insomnia (generally 7-10 days).
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Mylan claimed that for patients in whom the drug is used for more than 2-3 weeks, periodic reevaluation is recommended to determine whether there is a continuing need.
According to IMS Health, the additional strength, which had US sales of approximately $56m for the 12 months ending March 31, 2010, complements Mylan’s already approved and marketed strengths, which are therapeutically equivalent to Mallinckrodt’s Restoril 15mg, 22.5mg and 30mg for the short-term treatment of insomnia.
Reportedly, Mylan has 142 ANDAs pending FDA approval representing $95.6bn in annual brand sales. Thirty-seven of the pending ANDAs are opportunities represent $19.6bn in annual brand sales, for the 12 months ending December 31, 2009.