FDA approves additional use for Forteo
ROCKVILLE, Md. The Food and Drug Administration has approved a new use for an osteoporosis drug, the agency announced Wednesday.
The FDA said it approved Eli Lilly & Co.’s drug Forteo (teriparatide) as a treatment for glucocorticoid-induced osteoporosis in adults with high risk for fracture.
Since 2002, the drug has included a boxed warning – the FDA’s highest warning – about the risk of bone cancer in patients taking it. Because patients with GIO may be younger than the ones who usually take Forteo, the warning will be updated, the agency said.
FDA approves two-in-one blood pressure drug
EAST HANOVER, N.J. The Food and Drug Administration has approved a blood pressure pill that combines two drugs in one.
Novartis announced Tuesday that the FDA had approved Tekturna HCT (aliskiren and hydrochlorothiazide), which combines the existing treatment Tekturna with hydrochlorothiazide, a widely used diuretic.
The approval was based on a 2,700-patient clinical trial indicating that the combination of the two drugs reduced blood pressure more than either drug alone.
High blood pressure, also known as hypertension, affects nearly 74 million adults in the United States and is a major risk factor for cardiovascular disease.
GPhA, generic drug companies release letter regarding biosimilars bill
ARLINGTON, Va. An amendment to a health reform bill currently under consideration would preclude the development of a significant biosimilars industry, nearly 30 generic drug companies told three members of the House in a letter released Wednesday.
The Generic Pharmaceutical Association released the letter — written to Reps. Henry Waxman, D-Calif., Frank Pallone, D-N.J., and Nathan Deal, R-Ga. — signed by 27 generic drug makers criticizing the amendment to the House Energy and Commerce Committee’s health reform bill by Reps. Anna Eshoo, D-Calif., and Joe Barton, R-Texas, that would allow 12 years of market exclusivity for biotech drugs before they faced biosimilar competition.
“While safeguarding market protections and intellectual property rights is critical in the pharmaceutical sector, only a healthcare system that balances the interests of innovation and access to lower cost medicine will achieve the greatest success,” the companies wrote in the letter.
Signatories to the letter included generics companies such as Teva, Ranbaxy and Mylan, as well as Paddock Labs, Sovereign Pharmaceuticals and Spear Pharmaceuticals.