SUPPLIER NEWS — The Food and Drug Administration has approved Watson Pharmaceuticals’ Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure. It is a generic version of Teva Women’s Health’s Plan B One-Step, which had sales of about $88 million during the 12-month period ended in March, according to IMS Health.
The FDA has approved Lupin Pharmaceuticals’ pregabalin capsules in the 25-mg, 50-mg, 75-mg, 100-mg, 150-mg, 200-mg, 225-mg and 300-mg strengths. The drug is used to treat fibromyalgia, partial-onset seizures in adults, neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia. It is a generic version of C.P. Pharmaceuticals’ Lyrica, which had sales of about $1.8 billion during the 12-month period that ended in March, according to IMS Health.
The FDA has given priority review status to applications for Xarelto (rivaroxaban) as a treatment for deep-vein thrombosis — a condition in which clots form in one of the large deep veins, usually in the legs — and pulmonary embolism, which occurs when a DVT clot dislodges and is carried to the lung via the heart, Johnson & Johnson subsidiary Janssen Research & Development said.