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…on a lack of standing, the Plaintiffs amended their complaint in an attempt to cure any deficiencies. The amended complaint includes 8 counts: (1) that the FDA’s approval was unlawful…
…indicated in testimony before the Senate Finance Committee that the Agency was in the process of finalizing the proposal. Both pseudoephedrine and PPA are “List I chemicals” under DEA’s regulations. …
…Guides for drugs approved under [FDC Act § 505], and (2) the labeling for OTC drug products approved under [FDC Act § 505]. Although FDA received relatively few comments on…
…company’s efforts to obtain a PTE for U.S. Patent No. 5,817,338 (“the ‘338 patent”) covering PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets. As we previously reported, the PTO determined that the…
…for configurations of labeler codes, drug product codes, and package codes of 5-4-1 or 6-4-1, or 5-3-2 or 6-3-2. If a labeler code is 4 digits, it may only be…
…marketing. One point to bear in mind if you attempt to Google-search for the new database: an older and far more limited NIH database of dietary supplement labels remains online. …
…evaluation, participants will be asked to use the database and provide feedback. Participation can be in person in Washington, D.C. or online. Contact Kristina Schall at kristina.schall@opinionstrategies.com to sign up….
…is an attorney with Randy Pollack Law Office in Sacramento, CA. REMINDER: Register for HPM’s free webinar “The Evolution of the Park Doctrine” on October 8th. (link to registration: http://hpmwebinar.eventbrite.com/) …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC,…
…Tablets, 5 mg, and 10 mg ANDA No. 077431, Exemestane Tablets, 25 mg ANDA No. 076361, Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg ANDA No. 077179, Amlodipine besylate and…
…this case) would be 17 days after the anticipated April 6, 2010 approval deadline for ANDAs for generic COZAAR/HYZAAR. FDA’s opposition brief threw a new issue into the mix: did Teva…
…to further delay generic competition does not outweigh FDA’s interest in the thoughtful and careful exercise of its generic approval decisions without premature judicial interference. FDA’s efforts to get Teva’s…
…of the patent in the Orange Book could prevent additional generic competition until September 2007. Unless the D.C. Circuit reverses the district court’s decision on the issue of Mylan’s claim…
…eligibility for 180-day exclusivity. Judge Lamberth’s order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to relist the patent in the Orange Book and restore Teva’s…
…ideal candidate will have experience working at FDA or with a medical device company, and prior big law firm experience is helpful. Compensation is competitive and commensurate with experience. HP&M…