Apotex is working on a biosimilar of Amgen's Neulasta, but if and when it wins FDA approval, it'll have to wait awhile before launching, a court ruled on Wednesday.
The U.S. Supreme Court dealt a blow to Daiichi Sankyo and Mylan Pharmaceuticals when the court declined to hear their appeal in their attempt to head off drugmaker Apotex from introducing a generic version of the hypertension drug Benicar.
Within weeks of getting a conditional nod to resume shipments from two of the company's manufacturing units in India, Canada's largest generics maker has recalled 117,644 bottles of cevimeline hydrochloride capsules in the U.S. that were made by the company's Indian arm, Apotex Research, the Business Standard newspaper reports.
After the FDA banned a couple of Apotex's plants in India last year, Canadian Health Minister Rona Ambrose had Canadian regulators follow suit. Health Canada has now decided enough improvements have been made by Apotex to let the facilities off the hook, with provisos. The FDA's sanctions, however, remain solidly in place.
Canadian generics maker Apotex has seen Health Canada conditionally lift a ban against two of the company's manufacturing units in India after noting corrective work in progress has passed a threshold, the Toronto Star reports.
Canadian generics maker Apotex is recalling more than 35,000 bottles of generic Zyprexa, an antipsychotic, that were manufactured at a plant in Toronto that was recently nicked by the FDA for a number of issues.
Health Canada, which has been accused of not providing the public with enough info about quality concerns over the drugs sold there, says it will increase the number of plant inspections it will do and put more information online.
The FDA accepted Apotex's application to copy an Amgen blockbuster, giving the Canadian drugmaker a chance to cash in on the coming biosimilar boom in the U.S.
An Apotex plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.
Canadian generics maker Apotex is recalling tens of thousands of bottles of a blood pressure medication manufactured at a plant in India which the FDA banned after discovering it had been faking test data for years.