Novartis’ Tekturna HCT (aliskiren and hydrochlorothiazide) has been approved by the FDA as a single-tablet combination of two high blood pressure medicines designed to work together to lower blood pressure. Tekturna is a first in class renin inhibitor approved in the US in 2007 for treatment of hypertension. HCT, sometimes called a “water pill,” is one of the most commonly used high blood pressure medicines.
ZymoGenetics said the FDA has approved Recothrom thrombin, topical (recombinant), the first and only recombinant, plasma-free thrombin approved for use as a topical hemostat. Recothrom is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
Taro Pharmaceutical Industries said its US affiliate, Taro Pharmaceuticals USA, has received FDA approval for its NDA for Flo-Pred (prednisolone acetate oral suspension).The Flo-Pred brand, for which there are no generic equivalents, will be sold by prescription as an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications. The market for prednisolone oral liquid products was estimated at $55 million in 2007. The Company plans to launch the product later this year and market it through its TaroPharma Division of Taro USA.
Daiichi Sankyo said the FDA has approved Welchol (colesevelam HCl) indicated to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas or insulin, either alone or in combination with other anti-diabetic agents. Welchol is the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C).
