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…drug exclusivity for generic LUVOX CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg and 150 mg, nicely makes the point on how important dates are under the Hatch-Waxman Amendments. Anchen Pharmaceuticals,…
…two of which are relevant here: (AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant…
…preventing the parties from settling, it is likely that this bill will discourage generic drug companies from bringing challenges to brand companies’ patents in the first place—and as a result,…
…established pursuant to the Generic Drug User Fee Amendments of 2012 (“GDUFA”) for both Active Pharmaceutical Ingredient (“API”) and Finished Dosage Form (“FDF”) manufacturing facilities. The announcement comes after completion…
…(COMBAT) Act.” The COMBAT Act is the latest effort by Congress to incentivize the development of abuse-deterrent opioids. The bill also continues a trend of what we’ve termed “exclusivity stacking”…
In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order—Executive Order 14081—titled…
…for anti-competitive use of the Food and Drug Administration’s (FDA’s) citizen petition process to delay generic competition. The FTC sued Shire after the company exploited FDA’s petition process to an…
FDA has long taken the position that a Complete Response Letter (“CRL”)—a letter sent when FDA has determined that it “cannot approve” a New Drug Application (“NDA”) or an Abbreviated…
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food…
…announced that the U.S. District Court for the Northern District of Illinois, Eastern Division, granted the FTC’s request for a temporary restraining order on August 6, 2010, requiring the companies…
…States, and release into domestic commerce, of any future shipments of foreign-manufactured API for use in compounding non-customized 17P except in certain specified instances.” FDA argued that the Complaint should…
…practice.” 21 U.S.C. § 353(f)(1). Generally, an “order” is “lawful” if it is a prescription or, if an oral order, it is both promptly reduced to writing and filed by…
…previously ignored “red flags” and generally failed to exercise her corresponding responsibility in filling prescriptions. Wheatland Pharmacy; Decision and Order, 78 Fed. Reg. 69,441 (Nov. 19, 2013). While these factors…
…not be held in contempt, for failure to comply with the Court’s 2004 order that permanently enjoined DEA from regulating hemp fiber, stalk, sterilized seed and oil as controlled substances….
…and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a collagen scaffold device, marketed as Menaflex. The petition for review is the most recent…