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…such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section. That provision,…
…successful, more common diseases, such ALS and Alzheimer’s disease, would be prime candidates for dormant therapy development. Dr. Samuel Gandy, on behalf of Dr. Kenneth Davis, President and CEO of…
…identified in certain DESI proceedings noted in Docket Nos. FDA-1981-N-0077 (formerly 1981N-0393), FDA-1981-N-0248 (formerly 1981N-0396), FDA-1982-N-0046 (formerly 1982N-0095), FDA-1982-N-0264 (formerly 1982N-0096), and FDA-1983-N-0137 (formerly 1983N-0095), including products IRS to them. …
…at the center of the dispute, asserts the following method-of-use claim for YASMIN: A method of simultaneously achieving, during pre-menopause or menopause, a contraceptive effect, an anti-androgenic effect, and an…
…that [Franck’s] will resume the challenged conduct,” and the company “has turned in the permits required by Florida law to operate as a compounding pharmacy, sold all its assets, and…
…medical devices for which Cytori Therapeutics, Inc., of San Diego, California, sought clearance. The first device is called the Celution 700/LAB device, which Cytori’s brief describes as, in layman’s terms,…
…to increase survival after exposure to Soman “nerve gas” poisoning. More recently, in April 2012, FDA approved NDA supplements for LEVAQUIN (levofloxacin) Injection, Tablets, and Oral Solution for the treatment…
…current schedule III to the more restrictive schedule II. This rescheduling would affect popular hydrocodone combination products such as Vicodin, Lortab, Lorcet, Norco, Hycodan and Vicoprofen. (Bulk and single entity…
…unreviewable enforcement discretion. Thus, when Congress enacted the FDCA in 1938, it “quietly criminalized” all pharmacy compounding practices, yet had exercised enforcement discretion for 50 years. Franck’s chastises the government…
…use of BPA in infant formula and baby/toddler food packaging, in reusable food and beverage containers, and in canned food and beverage packaging (here, here, and here). Meanwhile, the…
…compliance” is not dispositive on the issue of whether agency action is final. See, .e.g., FDA Regulatory Procedures Manual, 4-1 (“Warning Letters are issued to achieve voluntary compliance . . ….
…tobacco packages, including “color graphics depicting the negative health consequences of smoking,” (2) the restrictions on distribution of samples, continuity programs, and promotion of brands through event sponsorship and merchandise,…
…for line extensions of oral solid dosage form innovator drugs, not only to new formulations, but new indications, combination products, and products marketed by companies independent of the company marketing…
…was represented by Hyman, Phelps & McNamara P.C.) (reply briefs here, here, and here), Judge Huvelle upheld FDA’s decision not to grant a period of 3-year Hatch-Waxman exclusivity in connection…
…patent”) covering ANGIOMAX (bivalirudin). As most folks know by now, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under NDA No. 020873, and MDCO submitted its PTE…