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Watson's generic Wellbutrin gets final FDA approval
27 Nov 2008
Regulatory Affairs
Watson Pharmaceuticals has said its generic version of GlaxoSmithKline's Wellbutrin XL has been granted approval in the US.
The company stated that its Laboratories division has received final approval from the Food and Drug Administration on its abbreviated new drug application for the product.
Bupropion Hydrochloride Extended-Release Tablets (XL) have been approved in the 150 milligram strength and are a generic version of Wellbutrin XL, which is used in the treatment of major depressive disorder.
Watson has indicated that it intends to launch the product without delay.
In a busy week for Watson, the company has entered into an agreement to acquire a portfolio of generic pharmaceutical products from Teva.
The acquisition of the products depends on the closure of the proposed merger between the Israeli pharmaceutical firm and Barr Pharmaceuticals.
If the deal goes through, Watson will purchase the portfolio for an upfront payment of $36 million (£23.3 million), with additional payments based on the achievement of certain milestones.
