The approval is the result of Watson’s agreement to a proposed consent order to divest certain products as a condition to obtaining FTC approval.
With the approval the two companies have obtained all regulatory formalities to close the transaction in late October or early November, according to Watson.
As part of the consent order, Watson will divest its pending applications for eight products and its morphine sulfate extended release capsules while Actavis will give away nifedipine, methylphenidate hydrochloride and ifedipine extended release tablets, Fentanyl transdermal film and Diltiazem Hydrochloride extended release capsules to Par Pharmaceutical.
The consent also provides Sandoz to acquire Actavis’ Bupropion Hydrochloride and Lorazepam tablets, Hydrochloride extended release capsules, including Watson’s pending application for Dextromethorphan Hydrobromide /Quinidine Sulfate.