The Center for Drug Evaluation (CDE) website shows that US-based Tris Pharma and Pediatrix Therapeutics’ methylphenidate hydrochloride sustained release chewable tablets, along with Ipsen Pharma’s injectable pamoic acid triptorelin injection, have been granted priority review status. The drugs are recognized for aligning with new pediatric drug varieties, dosage forms, and specifications tailored to pediatric physiological characteristics.
Drug Details
- Methylphenidate Hydrochloride Sustained Release Chewable Tablets: A central nervous system (CNS) stimulant for attention deficit hyperactivity disorder (ADHD), approved in the US in December 2015. It is the first chewable ADHD sustained release tablet.
- Pamoic Acid Triptorelin injection: A GnRH analog for locally advanced or metastatic prostate cancer, endometriosis, and central precocious puberty. Developed by Ipsen, it was first approved in 1986 and launched in China in 2003.-Fineline Info & Tech
