Tag Archives: generics
By Pharm Exec | Published: March 28, 2014
Adrian van den Hoven, Director General of the European Generics Association (EGA), this week called for the removal of barriers to generic medicines across the European Union.
By Reflector | Published: March 10, 2014
The plan to accelerate generic pricing and reimbursement has become another tragic European casualty, writes Brussels correspondent Reflector.
By Pharm Exec | Published: January 24, 2014
FDA has reported that it notified Ranbaxy Laboratories, Ltd., on Jan. 23 that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January […]
By Ben Comer | Published: January 21, 2014
Momenta Pharmaceuticals’ CEO Craig Wheeler said comments made by Teva leadership about a “purported” generic of Copaxone are “kind of humorous.” Teva’s Copaxone, a multiple sclerosis drug that earns nearly $4 billion a year, is approaching patent expiry – and possible generic competition – on May 24. Assuming FDA approves a generic version of Copaxone, […]
By Jill Wechsler | Published: November 11, 2013
FDA is proposing to revise its rules to permit generic drug manufacturers to initiate safety labeling changes, and not wait until the brand company takes that action. The aim of the new policy is to inform consumers more quickly of emerging safety concerns – but it also could create confusion by allowing prescribing information to […]