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Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More
Both sides in a patent lawsuit involving the drug Suprep are asking a federal appeals court to reconsider its opinion in the case, saying the court set a dangerous precedent for future Hatch-Waxman patent suits because it recognized infringement for unapproved uses and clouds the definition of “patient” when it comes to the patent claim. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
Pfizer suffered a setback May 20 in its efforts to defend itself against charges that a division of the company illegally slowed generic competition on the muscle relaxant Skelaxin. Read More
The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
House lawmakers advanced an FDA funding package that directs the agency to address a multitude of controversial issues, including justifying the costs to generic drugmakers of the agency’s proposed labeling overhaul. Read More
Generic drug giant Teva received FDA clearance May 30 to market exclusive versions of Pfizer’s blockbuster arthritis pain drug Celebrex (celecoxib) in the 100 mg, 200 mg and 400 mg capsule forms. Read More
Generic firm Mylan said Monday that it had reached a settlement with Pfizer to market versions of Celebrex (celecoxib), marking the latest twist in the generic conversion of the blockbuster arthritis pain drug. Read More
Eli Lilly said it will begin sharing clinical trial data used in support of regulatory filings in the U.S. and Europe with qualified researchers, becoming the latest drugmaker to join the growing clinical trial data transparency movement. Read More
The FDA is trying to encourage mobile app and web developers to give wide distribution to drug adverse events data by providing the data in an easy-to-use electronic format. Read More