Mylan Inc's subsidiary Mylan Pharmaceuticals Inc has launched Temazepam capsules USP, 7.5 mg.
This additional strength, which had US sales of approximately US$ 56 million for the 12 months ending March 31, 2010, according to IMS Health, complements Mylan's already approved and marketed strengths, which are therapeutically equivalent to Mallinckrodt's Restoril 15 mg, 22.5 mg and 30 mg for the short-term treatment of insomnia. The product is available for immediate shipment.
Currently, Mylan has 142 ANDAs pending US FDA approval representing US$ 95.6 billion in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.6 billion in annual brand sales, for the 12 months ending December 31, 2009, according to IMS Health.