Abbott announced that the FDA has approved its Humira Pen, a new device for administering Humira (adalimumab) treatment for moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Humira Pen will be available to US patients beginning in August.
The FDA has approved sales of Johnson & Johnson'sPrezista, to treat HIV infection. Also known as TMC114, Prezista is a protease inhibitor designed to treat resistant strains of the HIV virus that causes AIDS.
The FDA has approved Genentech’s Avastin (bevacizumab) in combination with intravenous 5-fluorouracil (5-FU)-based chemotherapy for second-line metastatic colorectal cancer. Avastin is also approved as a first-line treatment of metastatic colorectal cancer (CRC) in combination with intravenous 5-FU-based chemotherapy.
The FDA has approved the expanded indication of Allergan's once-daily prescription eye drop Lumigan (bimatoprost ophthalmic solution) 0.03% as a first-line treatment for elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension.
The FDA has approved Endo Pharmaceuticals' NDAs for Opana ER (oxymorphone hydrochloride) extended-release tablets and Opana (oxymorphone hydrochloride) immediate-release tablets. Opana ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Opana is indicated for the relief of moderate to severe acute pain for which the use of an opioid is appropriate.