FDA gives second orphan drug designation to Teva’s Treanda
JERUSALEM — The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.
Teva said the drug, Treanda (bendamustine hydrochloride), received the designation for indolent B-cell non-Hodgkins lymphoma through October 2015 that has progressed during or within six months of treatment with a regimen containing Rituxan (rituximab), marketed by Genentech and Biogen Idec. The FDA gives orphan drug designation to treatments for diseases affecting fewer than 200,000 people in the United States.
"Since 2008, Treanda has played a significant role in the treatment of patients with iNHL that has progressed," Teva Oncology VP and general manager Bill Campbell said. "We are pleased the FDA has recognized our commitment to treating patients with this rare form of cancer."
The drug is also used to treat chronic lymphocitic leukemia, for which it also received orphan drug designation through March 2015.
FDA approves Jubilant Life Sciences’ quetiapine fumarate tablets
NOIDA, India — The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.
Jubilant announced the approval of quetiapine fumarate tablets in the 25-mg strength. The drug is a generic version of AstraZeneca’s Seroquel.
Various versions of the drug have annual sales of about $59 million, according to IMS Health.
Sandoz to market authorized generic version of Adderall XR
PHILADELPHIA — Sandoz will market an authorized generic version of an attention deficit hyperactivity disorder drug made by Shire under a contract between the two companies, Shire said Monday.
Shire said Sandoz, the generics division of Swiss drug maker Novartis, would market an authorized generic version of Adderall XR (amphetamine; dextroamphetamine).
Under the five-year agreement, which became effective Sunday, Sandoz will begin marketing the product starting in July 2016. Shire will manufacture the drug, while Sandoz will market it and provide royalties on sales to Shire.
Authorized generics are branded drugs marketed under their generic names at a discounted price, usually under a contract between the branded drug’s manufacturer and a third-party company.