Roxane Labs’ generic prostate drug gets tentative approval from FDA
SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.
The FDA granted tentative approval to Roxane Labs’ dutasteride capsules in the 0.5-mg strength. The drug is a generic version of GSK’s Avodart, used to treat benign prostatic hyperplasia.
Tentative approval means that a drug meets the agency’s conditions for approval, but can’t receive final approval until Avodart loses its patent protection, which will occur in 2015.
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.