FDA gives tentative approval to Roxane pneumonia drug
SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.
According to the FDA’s website, the agency granted the preliminary authorization for Roxane Labs’ linezolid oral suspension in the 100-mg-per-5-mL strength.
The drug is a generic version of Pfizer’s Zyvox. Tentative approval means that the product meets the FDA’s requirements for approval, but the agency can’t approve it until patents covering the branded version expire; the first patent on the drug will expire in 2014.
Forest Labs buys rights to Merck’s Saphris
NEW YORK — Forest Labs is spending at least $240 million to buy rights to a psychiatric drug made by Merck, the New York-based drug maker said.
Forest said it would buy the U.S. rights for Merck’s Saphris (asenapine), a tablet dissolved under the tongue for the treatment of schizophrenia and manic episodes in patients with bipolar disorder. Forest will pay Merck $240 million upfront, as well as milestone payments based on sales, while Merck will supply the drug. Forest will market the drug and conduct clinical studies.
Saphris received approval from the Food and Drug Administration and launched in 2009. Merck reported net sales of $150 million for the drug during the 12-month period that ended in September.
Reports: R.I. may set up prescription drug registry to combat abuse
NEW YORK — Officials in Rhode Island may set up a registry that would allow doctors and pharmacists to track patients who have problems with drug abuse, according to published reports.
The Associated Press reported that the proposed registry would track prescriptions for drugs that are controlled substance and allow healthcare professionals to track their usage, similar to a monitoring program set up in New York this year. A task force that includes state lawmakers, health officials and healthcare professionals met Monday to look at the idea.
The AP reported that more than 180 residents of the state died from drug overdoses last year, including from illegal drugs and legal prescription drugs.