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…here), Zogenix first sued Massachusetts Governor Deval Patrick and other Commonwealth officials after the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, took actions to combat…
…process provides a pathway for adding an active ingredient to an existing over-the-counter (OTC) drug monograph. Under the TEA program, instituted in 2002, FDA will consider accepting an active ingredient…
…without any delay, the data are complete, FDA determines that the ingredient is GRASE, and the comment period for the proposed rule is limited to 90 days. The TEA process…
…order. FDA must grant meeting within 45 days after date of meeting Adcom: FDA may convene advisory committee (adcom). Final Order: 90 days after closing of comment period, if sufficient…
…(OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice,” FDA states in the notice. The second category includes drug products…
…with another FDA 180-day exclusivity forfeiture decision concerning the often-cited failure-to-obtain-timely-tentative-(or final)-approval forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV). The latest decision we obtained from FDA is interesting as it…
…Novartis relies on FDA’s March 15, 2010 citizen petition response to a Sandoz petition involving ACTOS (pioglitazone HCI) Tablets and ACTOPLUS MET (pioglitazone HCl; metformin HCI) Tablets to support its…
…days. Daiichi’s brief is on file, as well as a brief from cross-appellant Mylan challenging the District Court’s denial of the company’s motions to intervene and dismiss the Apotex Complaint. …
…to the December 2003 enactment of the Medicare Modernization Act (“MMA”) is alive and kicking. . . . and will likely be around for years to come. Sometimes FDA’s decisions…
…received a Complete Response Letter for this ANDA on March 13, 2013, which included the same bloequivalence deficiencies communicated in the Agency’s March 13, 2012 Bioequivalence Comments. Zydus promptly responded…
…the company to amend its patent certification to reflect that the ‘952 patent was no longer listed in the Orange Book as claiming RISPERDAL Tablets. Teva complied and submitted the…
…such as with prescription pain medication abuse (e.g., pill mills, doctor shopping). While many expressed that some of the deadlines in the bill might be unrealistic, there was general consensus…
…the FDC Act to require Country-Of-Origin (“COO”) labeling on prescription and Over-The-Counter (“OTC”) drug products. Specifically, the bill would amend FDC Act § 502 so that a prescription drug would…
…each prescription drug product, both new prescriptions and refills, approved under [FDC Act § 505] and dispensed to consumers by pharmacies and authorized dispensers in an outpatient setting. FDA is…
…to mitigate risk, including considering offering naloxone when factors that increase risk for opioid-related harms are present. Providers should review the patient’s history of controlled substance prescriptions using state Prescription…