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…a synthetic generic version of Premarin cannot be approved.” Instead, companies have generally pursued approval of 505(b)(2) NDAs – e.g., CENESTIN (synthetic conjugated estrogens, A) Tablets. Whether today, 17 years…
…to show that ANDA No. 78-278 is tentatively approved. FDA’s move could signal an end to the litigation. As we reported last Thurdsay, Novartis’s Complaint alleges that FDA failed to…
On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018)….
…formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP). Vanda Pharmaceuticals, Inc. v. Centers for Medicare and Medicaid Servs., No. 23-1457 (4th…
…orphan drug. FDA’s orphan drug regulations (21 C.F.R. Part 316) define a “clinically superior” drug as “a drug . . . shown to provide a significant therapeutic advantage over and…
…coma, among other things. FDA has yet to act on Public Citizen’s petition. FDA’s TFM for oral healthcare drug products was issued in 1991. At that time, FDA’s advisory review…
This was FDA’s recent admonition to ChemRite CoPac, Inc. (ChemRite), in a Warning Letter issued on June 29, 2017. Apparently the manufacturer of several over-the-counter oral rinses and oral moisturizing…
…marketed for decades without FDA approval. Then, in 2009, FDA approved Mutual Pharmaceutical Company, Inc.’s (and now Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”)) 505(b)(2) application (NDA No. 022352) for COLCRYS (colchicine)…
…to the market via an EUA for the time being, but at the same time, prepare for a traditional regulatory submission (e.g., 510(k) premarket notification, de novo request, or PMA)….
…Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Maryland 20852. Electronic registration and comments may be submitted via www.regulations.gov. FDA will accept public comments through February 28, 2010. …
…and a settlement agreement that is found to violate any one of various Federal and State laws. That’s a lot to digest . . . but there’s more. Title IV…
…with the 21 U.S.C. § 823(a) public interest factors and U.S. obligations under the Single Convention. 85 Fed. Reg. 82,334. DEA received 256 comments in response to its March 23,…
…especially when these unsafe products are priced more competitively than legitimate products (e.g., as seen with the supply of counterfeit Avastin distributed to U.S. oncology practices a year ago). Overall,…
…2021. So far, so good; just the typical approval and outcome you’d expect. But then things got interesting. . . really interesting . . . . As stated in Otsuka’s…
…“The Times is dinner, but The National Enquirer, that’s dessert.” Take, for example, recent statements made by Flamel Technologies (“Flamel”) with respect to the company’s AKOVAZ (ephedrine sulfate) Injection, 50…