Recent FDA Approvals (through May 2010) related to Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix
Naproxen and esomeprazole magnesium (Vimovo, AstraZeneca and Pozen) delayed-release tablets were approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Extended-release tramadol (CIP-Tramadol ER, Cipher) was approved for the treatment of moderate-to-moderately severe chronic pain in adults. Strengthened warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressants, and the risk of overdosage.
Gatifloxacin ophthalmic solution (Zymaxid, Allergan) 0.5% was approved for the treatment of bacterial conjunctivitis caused by susceptible strains of Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, and Streptococcus pneumoniae.
A 0.5-mg lower-dosage strength tablet of sirolimus (Rapamune, Pfizer) was approved for the prophylaxis of organ rejection in patients aged >13 years receiving kidney transplants, with specific regimens recommended for use in patients at low-to-moderate immunologic risk and in patients at high immunologic risk.
Ketorolac tromethamine nasal spray (Sprix, Roxro) was approved for the short-term (up to 5 days) management of acute moderate-to-moderately severe pain that requires analgesia at the opioid level.
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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