The FDA denied a petition seeking the withdrawal of the AMAG Pharmaceuticals hormone drug Makena (hydroxyprogesterone caproate), which a patients’ rights group argues has possible links to developmental abnormalities. Source:…
The Philadelphia District Attorney is suing opioid manufacturers and is the first to sue under Pennsylvania’s consumer protection law — making it a public enforcement action on behalf of all…
The FDA observed various GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Source: Drug Industry Daily
Bayer sued Perrigo for allegedly infringing on six patents in its ANDA for a generic version of its acne and rosacea treatment Finacea Foam (azeleic acid). Source: Drug Industry Daily
PhRMA and BIO called on U.S. trade officials to add the European Union to a list of countries that do not adequately protect intellectual property following the release of two…
The FDA released five guidances on treatments for a variety of neurological disorders including Duchenne muscular dystrophy and Alzheimer’s disease, offering suggestions for trial designs and methods of measuring effectiveness.…
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Source: Drug Industry Daily
An FDA advisory committee narrowly voted against recommending an additional nerve block indication for Pacira’s Exparel, a local analgesic approved in 2011 for post-surgical pain management. Source: Drug Industry Daily
The FDA sent a warning letter to Chinese manufacturer Guangzhou Baiyunshan for failing to follow proper cleaning, validation and storage procedures at its Guangzhou, Guangdong facility. Source: Drug Industry Daily
Medtech petitioned the FDA to allow the company to submit an ANDA for generic Excedrin in which the proposed product is in a dosage form different from the reference drug.…