FDA actions in brief
FDA approval information regarding zoledronic acid (Reclast injection), somatropin (rDNA origin) injection (Norditropin), clopidogrel 300-mg loading dose (Plavix), IV and oral levofloxacin (Levaquin), thrombin, topical (human) (Evithrom), amlodipine/olmesartan (Azor), and docetaxel injection concentrate (Taxotere)
Key Points
Zoledronic acid (Reclast Injection, Novartis) was approved for the once-yearly treatment of osteoporosis in postmenopausal women.
FDA approved somatropin (rDNA origin) injection (Norditropin, Novo Nordisk) for the treatment of children with short stature associated with Turner syndrome.
A 300-mg loading dose tablet of clopidogrel (Plavix, Sanofi-Aventis/Bristol-Myers Squibb) was approved for the reduction of atherothrombotic events.
Thrombin, topical (human) (Evithrom, Omrix) was approved as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical.
A combination of amlodipine and olmesartan (Azor, Daiichi Sankyo/Forest) was approved for the treatment of hypertension.
Docetaxel injection concentrate (Taxotere, Sanofi-Aventis) was approved in combination with cisplatin and 5-fluorouracil for induction therapy of locally advanced squamous cell carcinoma of the head and neck before patients undergo chemoradiotherapy and surgery.
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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