WESTON, Fla., Feb. 2, 2021 /PRNewswire/ - Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.
Biohaven Pharmaceutical Holding Co Ltd said on Friday the U.S. health regulator failed to approve its treatment for amyotrophic lateral sclerosis, or Lou Gehrig's disease, sending its shares down nearly 6% in extended trading.
An aspiring biosimilar manufacturer is employing a citizen’s petition in a novel way in hopes of setting regulatory approval standards. In a May 3 letter, Apotex asked the Food and Drug Administration to set a specific requirement for other biosimilar companies that, depending upon what the agency decides, may serve as a barrier to regulatory approval of their treatments.
Law360, New York (April 12, 2017, 7:47 PM EDT) -- The Federal Circuit on Wednesday affirmed the Patent Trial and Appeal Board's decision invalidating a patent covering Novartis' multiple sclerosis drug Gilenya, which had sales of $3.1 billion last year, in a win for generics makers Apotex, Mylan and Torrent Pharmaceuticals.
(Omeprazole): Dexcel v. Apotex