Focalin (Dexmethylphenidate HCL Tablets) Novartis

After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.

In 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.

A total of 17 lots are now part of the recall of Clonazepam because some cartons have the wrong strength on the label.

Relapsed or refractory acute leukemia with a KMT2A translocation currently has an overall survival rate of less than one year when treated with frontline therapies.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025, for reproxalap for patients with dry eye disease. Reproxalap also is being tested in allergic conjunctivitis.

Monjuvi is available under an accelerated approval to treat adults with relapsed or refractory diffuse large B-cell lymphoma.