Pipeline Preview
Recent FDA action (through January 2013) related to, IPX066, Afatinib, Enobosam, GTx-024, Elafin, Ezatiostat HCL, Tranexamic acid tablets, Lamotrigine extended-release tablets
Complete response
- IPX066 (Rytary, Impax Pharmaceuticals, a division of Impax Laboratories) extended-release capsule formulation of carbidopa-levodopa, for the symptomatic treatment of Parkinson’s disease. The complete response letter (CRL) indicated that FDA requires a satisfactory re-inspection of the company’s Hayward, Calif. facility as a result of the warning letter issued in May 2011 before the company’s NDA may be approved due to the facility’s involvement in the development of Rytary, and supportive manufacturing and distribution activities. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch. The company said it will work with FDA on the appropriate next steps for the Rytary application.
Fast-track designation
- Afatinib (Boehringer Ingelheim) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with an epidermal growth factor receptor mutation as detected by an FDA-approved test.
Priority review
- Enobosarm, GTx-024 (GTx) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.
Orphan drug designations
- Elafin (Proteo) for the treatment of pulmonary arterial hypertension.
- Ezatiostat HCL (Telintra, Telik), for the treatment of myelodysplastic syndrome.
First-time generic approvals
Tranexamic acid tablets (equiv to Lysteda)
Watson
Lamotrigine extended-release tablets in 25-mg, 50-mg, 100-mg, 200-mg, and 300-mg strengths (equiv to Lamictal XR)
Wockhardt
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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