By Ricardo Carvajal & Diane B. McColl – FDA issued warning letters to the manufacturers of certain caffeinated alcoholic malt beverages contending that the products are adulterated under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) because caffeine is not an approved food additive for …
By Kurt R. Karst – Sandoz Inc.’s recent Complaint filed in the U.S. District Court for the District of Columbia concerning Orange Book-listed U.S. Patent No. 7,429,602 (“the ‘602 patent”) covering ELESTAT (epinastine HCl) Ophthalmic Solution, could, if successful, serve as a model for future cases …
By Kurt R. Karst – Last month FDA responded to an August 25, 2010 request from New Jersey State Senator Joseph F. Vitale (D) concerning pending legislation – Assembly Bill 1995 (the State Senate version of which is Senate Bill 961) – that, if enacted, would …
By Ricardo Carvajal – An article in the current edition of the Food and Drug Law Institute’s Update discusses a recent development in the European Union's regulation on health claims used in food labeling that could have the effect of suppressing publication of scientific research on …
On December 9, 2010, Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will speak at a webinar on accelerated drug and biologic approvals. In 1992, FDA published final regulations providing for the “accelerated approval” of applications for certain new drugs and biologics. Section 506 of the …
By William T. Koustas – The confirmation hearing for Michele M. Leonhart for the Administrator of the U.S. Drug Enforcement Administration (“DEA”) was held by the Senate Judiciary Committee on Wednesday, November 17, 2010. Ms. Leonhart has been Acting DEA Administrator since the resignation of former …
By Kurt R. Karst – In a November 16th decision that might not mark the end to the dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products, Judge Alan Johnson from the …
By Kurt R. Karst – Following up on a June 11, 2010 invitation from the U.S. Court of Appeals for the Sixth Circuit to file an amicus brief in the consolidated appeals of Smith v. Wyeth, Inc. (Case No. 09-5460), Wilson v. Pliva, Inc. (Case No. …
By Kurt R. Karst– The generic drug industry is headed for its own version of a “patent cliff” – a “180-day exclusivity cliff” – according to a report from MorganStanley on large cap and specialty pharmaceuticals issued earlier this month. “Patent cliff” is a colloquial term …
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Ricardo Carvajal has been named Director of the firm, and that Dara Katcher Levy has been named Of Counsel. Mr. Carvajal’s practice focuses on providing FDA and FTC regulatory counseling and litigation support to …
By Dara Katcher Levy – We previously blogged about the Amphastar lawsuit – a suit seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of semi-purified heparin. Amphastar had responded to each of FDA's allegations, however, the shipments remained detained. On November …
By Kurt R. Karst – In our post last week on letters issued by the U.S. Patent and Trademark Office (“PTO”) clarifying when patents covering certain drug products are eligible for a Patent Term Extension (“PTE”) in light of the U.S. Court of Appeals for the Federal …
By Dara Katcher Levy – The government is surely persistent when it comes to imported products that relate to FDA. On November 2, 2010, the U.S. Court of International Trade denied the U.S.’s application for a default judgment of $17,734,926 against a British corporation that many years …
By Alan M. Kirschenbaum – The Centers for Medicare & Medicaid Services (“CMS”) has finalized the withdrawal of its regulations on the calculation of Average Manufacturer Price (“AMP”) and the determination of federal upper limits. As we previously reported, CMS is withdrawing these regulations because they …
By Ricardo Carvajal – The graphic artists working on behalf of FDA have been busy, busy, busy! The agency posted 36 proposed graphic health warnings that would accompany the new health warning statements required under section 201 of the Family Smoking Prevention and Tobacco Control Act. …
