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Showing posts from September, 2021

Mystery: is there a difference between ASTEPRO ALLERGY and Children’s ASTEPRO ALLERGY?

  Orange Book Insights No. 27 –  Mystery: is there a difference between ASTEPRO ALLERGY and Children’s ASTEPRO ALLERGY ? Two nasal sprays containing azelastine hydrochloride were approved under NDA 213872 on June 17, 2021. They were named ASTEPRO ALLERGY (Prod. No. 001) and  Children’s  ASTEPRO ALLERGY (Prod. No. 002). Both have a strength of 0.2055mg/spray. The directions for use are also identical. For example, Prod. No. 001 has the same directions for use by children as Prod. No. 002. Similarly, Prod. No. 002 has the same directions for use by adults as Prod. No. 001. The inactive ingredients of the two versions are identical and listed in the same order. What brought these products to my attention was the Supplement 7 “What’s New” of my Orange Book Companion . The “What’s New” showed that, after the June 17 approval of the both products, three patents were listed for Prod. No. 001, but none for the Prod. No. 002 “children’s” version. The claims of the three listed patents did not