Menu
Your search for “ 🐧 Stromectol 6mg Tablets Canada 🆗 www.Ivermectin-OTC.com 🆗 Stromectol Without A Doctor Prescription 🏍 Ivermectin For Humans Over The Counter - Buy Stromectol 3mg Online Usa” returned the following results.
With the new Over-the-Counter (OTC) Monograph Reform came new facility fees (see our blog posts here and here, and FDA’s announcement here), and with new fees comes the new Arrears…
…a “Workshop” to examine advertising for over-the-counter (OTC) homeopathic products on September 21. FDA’s Federal Register Notice for the hearing identified issues to be discussed that were careful to avoid…
…a 96-page final rule concerning new organ-specific warnings and related labeling for Over-The-Counter (“OTC”) Internal Analgesic, Antipyretic, and Antirheumatic (“IAAA”) drug products was posted and then quickly removed from the…
…request that FDA “explain and reconsider this departure from decades of settled practice.” House Energy and Commerce Committee Chairman Fred Upton (R-MI) reiterated this message in a press release announcing…
…week, FTC staff announced that it has submitted a comment to FDA. The comment was approved by the Commission by a vote of 5-0. Not surprisingly, FTC staff takes the…
…2009 – that would have required new organ-specific warnings and related labeling for Over-The-Counter (“OTC”) Internal Analgesic, Antipyretic, and Antirheumatic (“IAAA”) drug products. The final rule included the following statements…
…OTC drug products are often manufactured by a single manufacturer for many private label distributors. As long as the finished product is ultimately compliant, FDA’s refusal to permit the import…
…(1) identify Over-the-Counter (“OTC”) drug products that contain nanoscale versions of ingredients in an OTC drug monograph; (2) identify nanoscale versions of food and color additives; (3) address the safety…
…Court for the District of New Jersey concerning Wyeth Pharmaceuticals Inc.’s (“Wyeth’s”) anti-depressant drug EFFEXOR XR (venlafaxine HCl) Extended-release Tablets. In a December 2011 Complaint, several direct purchasers allege that…
By Kurt R. Karst – When we last blogged on the issue of 180-day exclusivity for generic versions of Merck & Co., Inc.’s blockbuster drugs COZAAR (losartan potassium) Tablets…
By Kurt R. Karst – As folks in the Hatch-Waxman community patiently await FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve…
…Teva Pharmaceuticals USA, Inc. (“Teva”) filed a Complaint and a Motion for Preliminary Injunctive Relief against FDA concerning 180-day exclusivity forfeiture for generic versions of Merck & Co., Inc.’s (“Merck’s”)…
By Kurt R. Karst – We recently reported on a Complaint and a Motion for Preliminary Injunction Teva Pharmaceuticals USA, Inc. (“Teva”) filed in the U.S. District Court for the…
…version of the company’s blockbuster antipsychotic drug SEROQUEL (quetiapine fumarate) Tablets (NDA No. 020639) as early as March 26, 2012 (as well as an extended-release version of the drug, SEROQUEL…
By Kurt R. Karst – A little over three months ago, we on a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”)…