Report: Exclusivity period for biotech drugs may be reduced to seven years
WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.
According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.
The administration originally supported a seven-year exclusivity period while the biosimilars provision still was under debate in Congress, though the final version of the healthcare bill that President Obama signed into law allowed for 12 years. The 12-year period was favored by branded drug and biotech companies, while the generic drug industry wanted an exclusivity period of five years, as pharmaceutical drugs have.
The data exclusivity period is the amount of time the Food and Drug Administration must wait after approving the branded version of a drug before it can accept an application for a generic or biosimilar version.
FDA OKs Abilify as maintenance treatment for bipolar disorder
PRINCETON, N.J. — The Food and Drug Administration has approved a psychiatric drug for treating bipolar disorder when used in combination with one of two other drugs.
The FDA approved Abilify (aripiprazole), made by Bristol-Myers Squibb and Otsuka Pharmaceutical, as an adjunct to lithium or valproate for maintenance treatment of bipolar I disorder.
The FDA approved Abilify as an adjunct to lithium or valproate for acute treatment of manic or mixed episodes associated with bipolar I disorder in May 2008. The drug also is approved as a stand-alone treatment for the disorder.
Teva’s Jinteli now available
NORTH WALES, Pa. — Generic drug maker Teva Pharmaceutical Industries has launched a generic drug for treating symptoms of menopause.
Teva announced Thursday the availability of Jinteli (norethindrone acetate and ethinyl estradiol) tablets.
The drug is a generic version of Warner Chilcott’s FemHRT and is available in the 1-mg/5-mcg strength.