September FDA Pipeline
New combinations
New combinationsVytorin
Ezetimibe and simvastatin
MERCK/SCHERING-PLOUGH
Cost. The ezetimibe/simvastatin combination tablet will be priced at $2.34 per dose for all doses, according to the manufacturer.
New indicationsAldara
Imiquimod cream, 5%
3M PHARMACEUTICALS
IMMUNE RESPONSE MODIFIER APPROVED FOR SUPERFICIAL BASAL CELL CARCINOMA
Atazanavir (Reyataz, Bristol-Myers Squibb) was approved for use with low-dose ritonavir (Norvir, Abbott) in treatment-experienced HIV-infected patients.
FDA approved levofloxacin tablets/injection and levofloxacin in 5% dextrose injection (Levaquin, Johnson & Johnson) to treat multi-drug resistant strains of Streptococcus pneumoniae in community-acquired pneumonia (CAP).
FDA approved lansoprazole (Prevacid, TAP Pharmaceutical Products) for the short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in adolescent patients aged 12 to 17 years. Also approved was a delayed-release, orally disintegrating tablet formulation of lansoprazole (Prevacid SoluTab, TAP Pharmaceutical Products), which can be administered via an oral syringe or nasogastric tube.
Intradermal botulinum toxin type A (Botox, Allergan) was approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
FDA approved additional efficacy labeling for quetiapine (Seroquel, AstraZeneca). The data demonstrated that after 12 weeks, approximately two-thirds of patients receiving quetiapine as monotherapy achieved remission. The new label includes safety and efficacy data for mania associated with bipolar disorder extending up to Week 12.
Experts Explore Causes and Care for Chronic Itch
April 22nd 2025In a recent discussion with Managed Healthcare Executive, three leading dermatologists and itch experts—Shawn Kwatra, M.D., Brian Kim, M.D., and Gil Yosipovitch, M.D.—shared where the science is going, what’s holding it back and how the healthcare system can better support patients.
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David Calabrese of OptumRx Talks New Role, Market Insulin Prices and Other Topics 'On His Mind'
April 13th 2023In this month’s episode of the "What's On Your Mind podcast," Peter Wehrwein, managing editor of MHE connects with the now Chief Clinical Officer of OptumRx Integrated Pharmacies, David Calabrese. In this conversation, David touches on his transition in January as OptumRx’s former chief pharmacy officer and market president of health plans and PBMs to his new role as Chief Clinical Officer where he now focuses more on things such as specialty pharmacy to home delivery — with an overall goal of creating whole-patient care. Throughout the conversation, Calabrese also touched on the market’s hot topic of insulin prices and behavioral health services within the OptumRx community, among other topics.
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Insights Into Chronic Itch From Shawn Kwatra, M.D.
April 15th 2025A Q&A between Shawn Kwatra, M.D., professor and chair of dermatology at the University of Maryland School of Medicine, and Managed Healthcare Executive about new discoveries in chronic itch, how treatment options are improving and the challenges patients face in getting access to the right therapies.
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Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.
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