PFI ANDA
This article was originally published in The Tan Sheet
Executive Summary
Pharmaceutical Formulations, Inc.'s ibuprofen/pseudoephedrine hydrochloride tablets (Whitehall-Robins' Advil Cold & Sinus) approved by FDA April 8. ANDA 75-588 marks second private label approval referencing the analgesic. Ranbaxy Pharmaceuticals subsidiary Ohm Labs, which licensed its product to Perrigo, received 180-day, first-to-file exclusivity (1"The Tan Sheet" May 7, 2001, p. 8)...
Pharmaceutical Formulations, Inc.'s ibuprofen/pseudoephedrine hydrochloride tablets (Whitehall-Robins' Advil Cold & Sinus) approved by FDA April 8. ANDA 75-588 marks second private label approval referencing the analgesic. Ranbaxy Pharmaceuticals subsidiary Ohm Labs, which licensed its product to Perrigo, received 180-day, first-to-file exclusivity (1 (Also see "Perrigo New Product Launches, PPA Replacements Slated For August" - Pink Sheet, 7 May, 2001.), p. 8).... |