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…in the book this blogger authors – Generic and Innovator Drugs: A Guide to FDA Approval Requirements – exploring nearly all of the Orange Book minutiae you can imagine, the…
…FDA: In November 2013, the FDA granted the Company tentative approvals for the 5 mg, 10 mg, 20 mg, and 40 mg strengths of its generic Focalin XR®. In June…
By Kurt R. Karst – There’s no two ways about it: We love data. And it doesn’t really matter what FDA-related topic those data concern: citizen petitions (here and here),…
…by Mylan Pharmaceuticals Inc. (“Mylan”) alleging that Celgene violated federal and state antitrust laws by preventing generic competition for two of Celgene’s drug products: THALOMID (thalidomide) Capsules (NDA 020785) and…
…the IRS acknowledges in the preamble that certain generic drugs were approved under NDAs prior to the enactment of the Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman…
…Generic Drug User Fee Amendments (“GDUFA” ), FDA announced the release of two draft guidance documents that explain how the Agency (and the Office of Generic Drugs in particular) intends…
…generic competition issues. It follows recent FDA citizen petition decisions (here and here) and antitrust litigation that recently (and once again) brought the Federal Trade Commission into the fray (here…
…2008 brought by Lannett Company, Inc. against Celgene involving THALOMID, restricted distribution, and generic competition issues was also dismissed after a settlement between the parties. (See our previous post here.)…
…change, the data are intended to “help generic manufacturers determine the earliest date when they may be able to market new generic medicines.” This is a big – and important…
…product counterpart. Last Friday, Amgen Inc. (“Amgen”) further turned up the heat when the company announced the submission of extensive comments (89 pages in length) to two citizen petitions submitted…
…a 30-month stay on FDA’s approval of a generic drug application. (The most recent case we can think of is from 2009, when the U.S. Court of Appeals for the…
By Kurt R. Karst – Late on May 17th, the U.S. Court of Appeals for the District of Columbia Circuit denied, in separate orders (here and here), FDA’s petition for panel…
…strengths: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg. The 8 strengths were approved in a staggered fashion, instead of simultaneously:…
By Kurt R. Karst – FDA’s recent approval of an ANDA submitted by Perrigo R&D Company (“Perrigo”) for a generic version of the over-the-counter drug MONISTAT 1 Combination Pack…
…strategies companies come up with to protect their market exclusivity. Two strategies have recently come by our desks – one from a brand-name company related to New Chemical Entity (“NCE”)…