Menu
Your search for “ ���� Cattle Ivermectin ���� www.Ivermectin-Stromectol.com ���� Guinea Pig Mites Ivermectin ���� Oral Ivermectin , Ivermectin Pi” returned the following results.
…schedule II security, quota, recordkeeping, ARCOS reporting and order form requirements. Tapentadol is manufactured by Janssen Ortho, LLC, in doses of 50, 75 and 100 mg oral tablets. DEA requires…
The years-long battle over 5-year New Chemical Entity (“NCE”) exclusivity for Ferring Pharmaceuticals Inc.’s (“Ferring’s”) colonoscopy preparation, PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution (NDA 202535;…
…reported, on September 12, 2008 (the same day that oral argument was heard), a 3-judge panel of Circuit Judges Brown, Kavanaugh, and Senior Circuit Judge Williams filed a per curiam…
…one patent covering RISPERDAL, U.S. Patent #4,804,663, which expired on December 29, 2007, but that is covered by a period of pediatric exclusivity expiring on June 29, 2008. On March…
…FDA essentially undo what it did in 2009. Pyridoxamine is a form of vitamin B6. In July 1999, BioStratum Inc., a pharmaceutical company, filed an IND with FDA to study…
…18, 2009 ruling), and then denied Sanofi’s request for a stay. See Sanofi-Aventis, et al. v. Sandoz, et al., No. 3:07-cv-2762 (D.N.J. Jun 30, 2009). Sanofi promptly appealed the decision…
…Inc. (collectively “Lannett”) filed in June 2016 challenging FDA’s rescission of Lannett’s ANDA 202750 for the oral chemotherapy drug Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180…
On December 18, 2017, FDA announced the availability of a new draft guidance for homeopathic drugs. This guidance, when finalized, will replace the compliance policy guide (CPG) 400.400 from 1988….
…alternative calculation formula, enacted in 2010 as part of the Affordable Care Act, did not work as intended, and has now been corrected by BBA 2018. Before BBA 2018, the…
Well, that was quick! Only two weeks after filing, the U.S. District Court of Delaware dismissed Genentech’s Complaint under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen. As…
…will have an opportunity to provide oral comments during the public meeting as well as written comments to the docket. Comments previously submitted in response to the July 12, 2018…
…FDA apparently refused to approve NDA 209155 based on a litany of deficiencies, including chemistry, manufacturing, and controls, GMP issues, failure to comply with patent certification requirements, impurity problems, and…
…Narcotic Drugs, 1961 (“Single Convention”), the Agency’s action must comport with the requirements of the treaty. Cannabis, cannabis resin and extracts and tinctures of cannabis are listed in Schedule I…
…completed and pending oral argument. Meanwhile, the FTC is facing a ViroPharma problem. Courts are re-examining their historical reliance on the Commission’s assertions that, pursuant to section 13(b), a defendant…
…high-stakes regulatory submissions, Mike has litigated a number of significant Hatch-Waxman matters arising from the award or denial of 180-day exclusivity, 3-year and 5-year exclusivity, orphan drug exclusivity, 30-month stays,…