Recent FDA action (through April 2012) related to, Dihydroergotamine, Levadex inhalation aerosol, droxidopa, Northera, Amitriptyline 4% ketamine 2% cream, AmiKet, Afilbercept, ZALTRAP, Nav rAAV8 vector, Carbamazepine, Carbatrol, Vancomycin hydrochloride, Vancocin, Irbesartan, irbesartan-hydrochloriderothiazide, Avapro, Avalide, Fluvastatin, Lescol
Complete response
Fast-track designation
Priority review
First-time generic approvals
Carbamazepine extended-release capsules in 100-mg, 200-mg, and 300-mg strengths (equiv to Carbatrol)
PRASCO LABORATORIES
Vancomycin hydrochloride, USP Capsules (equiv to Vancocin)
VIROPHARMA
Irbesartan and irbesartan-hydrochlorothiazide tablets (equiv to Avapro and Avalide tablets)
TEVA
Fluvastatin capules USP, 20-mg and 40-mg strengths (equiv to Lescol)
MYLAN
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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ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
December 19th 2024The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.
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