Archive for March 2018

The FDA warned Clover Custom Blending after an investigation of its Tampa, Florida-based manufacturing plant revealed uninvestigated out-of-specification results, missing written procedures and other deficiencies. Source: Drug Industry Daily

Deltona, Florida-based MyNicNaxs entered into a consent decree after admitting to marketing unapproved drugs and misbranding. Source: Drug Industry Daily

Two drug compounders found themselves caught up in FDA’s increased focus on drug compounding when they were slapped with warning letters for the production of adulterated drugs and for sterility concerns. Source: Drug Industry Daily

In a retrial, a jury ordered AbbVie to pay more than $3 million to a plaintiff who blamed his heart attack on misrepresentation of the risks posed by AbbVie’s testosterone replacement drug AndroGel. Source: Drug Industry Daily

Senate Health Committee Chairman Lamar Alexander (R-Tenn.) released two draft bills that would provide the FDA with more tools to deal with the opioid crisis. Source: Drug Industry Daily

The Psychopharmacologic Drugs Advisory Committee voted to recommend approval of an NDA for lofexidine hydrochloride for mitigation of opioid withdrawal symptoms. Source: Drug Industry Daily

An FDA inspection of drugmaker Goran Pharma in November netted the company a Form 483 with 17 observations ranging from inadequate employee training to laboratory deficiencies and contamination risks. Source: Drug Industry Daily

A Delaware federal judge found generic drug developer Alvogen did not infringe on three Invidior patents for the opioid addiction drug Suboxone, specifically relating to the process for drying Suboxone’s sublingual film. Source: Drug Industry Daily

The FDA should avoid duplicating existing requirements in its updated guidance on chemistry, manufacturing and controls information for biologics, according to PhRMA and several drugmakers in comments to the agency. Source: Drug Industry Daily

The FDA issued guidance for sponsors developing chronic obstructive pulmonary disease (COPD) treatments, clarifying how to efficiently use the St. George’s Respiratory Questionnaire a patient-reported outcome measure assessment tool. Source: Drug Industry Daily