New Rx, OTC, and generics (May 2010)

May 5, 2010

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

Key Points

RX CARE

New drugs

Somaxon announced FDA approval of Silenor (doxepin) for the treatment in adults and elderly patients of both transient and chronic insomnia characterized by difficulty with sleep maintenance. ( http://www.silenor. com/ 858-480-0400)

Boehringer Ingelheim announced FDA approval of once-daily Mirapex ER (pramipexole dihydrochloride) extended-release tablets to treat signs and symptoms of idiopathic Parkinson's disease (PD) in its early and advanced forms. PD is the second most common chronic neurological disorder in older adults after Alzheimer's, and there is no known cure. (http://us.boehringer-ingelheim.com/)

Arbor has launched Pediaderm HC Complete Kit, containing Pediaderm HC (hydrocortisone lotion 2%) and nonsteroidal Pediaderm Protective Emollient, indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ( http://www.pediaderm. com/ 888-543-7797)

Takeda announced that Kapidex (dexlansoprazole) delayed-release capsules will be marketed under the new trade name of Dexilant. [See FDA Safety Page for details.] Capsule appearance remains the same. Dexilant is indicated for treatment of erosive esophagitis (EE) and heartburn related to non-erosive gastroesophageal reflux disease (GERD).( http://www.tpna.com/ 877-TAKEDA-7).

New indications

FDA approved Allergan's Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Its black-box warning states that effects may spread from the area of injection and cause symptoms that include swallowing and breathing difficulties that can be life-threatening. (714-246-4500)

FDA has approved Salix's Xifaxan (rifaximin) to reduce risk of recurrence of overt hepatic encephalopathy in patients with advanced liver disease. Xifaxan was already approved for treatment of traveler's diarrhea. ( http://www.salix.com/ 919-862-1000)

New generics

Covidien announced that Mallinckrodt, a Covidien company, has launched its oral transmucosal fentanyl citrate (CII) (comparable to Cephalon's branded Actiq). This Class II controlled substance is an opioid analgesic indicated only for the management of breakthrough cancer pain in patients aged ≥16 years with malignancies. (http://otfc.mallinckrodt.com/ 800-778-7898)

Impax announced FDA approval of its Abbreviated New Drug Application (ANDA) for tamsulosin hydrochloride 0.4-mg capsules (the generic version of Flomax) for treatment of signs and symptoms of benign prostatic hyperplasia. (products@impaxlabs.com/ 510-476-2000)

FDA has approved Fougera's imiquimod cream 5%, the generic equivalent to Graceway's Aldara, indicated for treatment of external genital and perianal warts, as well as for treatment of AK on the face or scalp, and for superficial basal cell carcinoma when surgery is impractical. ( http://www.fougera.com/ 800-645-9833)