In its fourth trip to the FDA, Endo's testosterone-boosting Aveed finally won over regulators, but as the clamor over risks tied to "low-T" treatments reaches deafening volume, the in-transition drugmaker may be late to a profitable party.
As the company points out, it's the only product cleared for patients whose chronic spontaneous urticaria haven't responded to antihistamines.
The FDA placed an import ban on products from Ranbaxy Laboratories' active pharmaceutical plant in Toansa, India, in January, calling into question its drug analysis and sanitation. But there are other problems at the plant, like worker safety, that the FDA does not address and which get little attention from Indian authorities.
One of the signal achievements for the biotech industry in the Affordable Care Act was a provision granting 12 years of market exclusivity to biologics. The decade-plus period of protection against generic competition ensured that biologics would remain center stage in the R&D world, especially as Big Pharma tumbled over the patent cliff as it tried to rethink its megablockbuster-sized budgets for drug development.
After their antitrust-fighting colleagues levied $251 million in fines against Swiss drugmakers Roche and Novartis on allegations that they colluded to protect sales of their eye drug, Italian prosecutors are now investigating possible market manipulation and fraud, according to Reuters.
For Endo's testosterone therapy Aveed, the third time wasn't the charm with the FDA--but the fourth time was. After a trio of rejections, the FDA has given the thumbs up to the Low-T drug, and the Malvern, PA-based company expects to launch it this month. But amid the safety questions surrounding testosterone drugs, doing so may not be so easy.
Baxter International, which has had ongoing contamination issues with some of its intravenous products, is now recalling one lot of a peritoneal product used on dialysis patients. It says the lot is contaminated with mold. The announcement, also sent out by the FDA, says there have been adverse reactions reported.
The FDA has held off approval of a new Eli Lilly diabetes drug until partner Boehringer Ingelheim fixes problems at a plant that last year was slapped with a warning letter.
Eli Lilly is staring down the barrel of its Evista patent expiration. And Tuesday, Teva Pharmaceutical Industries won FDA approval to load the bullet. The company's generic version of Lilly's breast cancer and osteoporosis drug got the green light, and Teva says it will hit the U.S. market within a month.
The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.