New products for pharmacists: Rx, OTC, and generics (March 2012)


A survey of new Rx, new generic, and new OTC products


New drugs

FDA has approved Roche's Erivedge (vismodegib) capsule for adults with metastatic basal cell carcinoma (BCC) or locally advanced BCC that has recurred after surgery or cannot be treated with surgery or radiation. The capsule is taken orally once a day. Erivedge is available through specialty pharmacies. ( 650-225-1000)

Boehringer Ingelheim Pharmaceuticals and Eli Lilly announced that FDA has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, which combine the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto is prescribed along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. (

Oxecta Tablets CII are now commercially available from Pfizer. Oxecta (oxycodone HCl, USP), a pain medication that uses Acura Pharmaceuticals' Aversion Technology, will be sold in bottles of 100 tablets in 5-mg and 7.5-mg strengths. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. ( 847-705-7709)

Insys Therapeutics announces FDA approval of its cancer pain medication, Subsys fentanyl sublingual spray. This medication, with a novel delivery device, offers numerous benefits to patients who experience episodes of breakthrough cancer pain. Subsys is approved in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ( 602-910-2617)

Upsher-Smith Labs has launched a prenatal vitamin, B-Nexa, the only prescription vitamin formulated with ginger and vitamin B6 to help ease morning sickness. B-Nexa does not contain antihistamine. ( 888-650-3789)

FDA has approved Pfizer's Inlyta (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of 1 prior systemic therapy. This oral therapy was designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which are receptors that can influence tumor growth, vascular angiogenesis, and progression of cancer. ( 800-505-4426)

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