Teva receives FDA action letter for generic Lovenox
JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.
The drug maker said the FDA sent a minor deficiency letter, which indicated the regulatory agency completed its review of the abbreviated new drug application for generic Lovenox (enoxaparin sodium) injection, as well as Teva’s responses to key questions during the review process. Prior to potential final product approval, Teva also needs to respond to questions posed by the Office of Generic Drugs, which the drug maker said it will answer in the near future.
Lovenox, designed to treat deep vein thrombosis, is made by Sanofi-Aventis.
Mylan announces Lipitor, Caduet patent settlements
PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.
Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).
Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.
Caduet had sales of $389 million during the 12-month period ended in September 2010, according to IMS Health, while Lipitor had sales of $7.27 during the same period.
Head of Lilly’s oncology biz resigns
INDIANAPOLIS — John Johnson is bidding Eli Lilly adieu.
Johnson, who served as SVP and president of the drug maker’s oncology business — whose portfolio includes Alimta (pemetrexed) and Gemzar (gemcitabine hydrochloride) — resigned, effective Jan. 28. Johnson is taking on the chief executive role at specialty biopharmaceutical company Savient, effective Jan. 31. Savient is best known for its chronic gout treatment Krystexxa (pegloticase), which received regulatory approval in September 2010.
Johnson said that his role at Savient will focus on successfully launching Krystexxa on a global scale.
"I am thrilled to be joining Savient at this exciting time," Johnson said. "Krystexxa is a product that has potential to make a significant difference in the lives of patients around the world. I look forward to working with the dedicated and talented Savient employees to bring relief to those adult patients suffering from chronic gout refractory to conventional therapy."