FDA approves 1st generic under new pathway & 2 other drugs this week

Mackenzie Bean (Twitter) -

Here are the three latest drugs or medical devices approved by the FDA since Aug. 3:

1. Jornay PM is a new formulation of the ADHD drug methylphenidate, which patients take at night to reduce the severity of ADHD symptoms the next day.

2. Poteligeo injection is intended to treat two rare forms of Non-Hodgkin lymphoma: Mycosis fungoides and Sézary syndrome. The medication is the first drug approved to treat the latter condition.

3. Apotex's potassium chloride oral solution is used to treat low potassium levels in the blood and represents the first generic drug approved under the FDA's Competitive Generic Therapy pathway.

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