Linex Legal (registration) (press release) Other regulations at 21 C.F.R. § 314.94(a)(9)(iv) identify exception excipients for generic ophthalmic and otic drug products (i.e., preservative, buffer, substance to adjust tonicity, and thickening agent ). Excipients not identified in these ...
Linex Legal (registration) (press release) ... filed earlier this month, Novartis Pharmaceuticals Corporation (“NPC”) is appealing a February 2013 decision (unpublished) from the U.S. Court of Appeals for the Fourth Circuit involving NPS drugs AREDIA ( pamidronate disodium ) and ZOMETA ...
