New Products for Pharmacists: Rx, OTC, and generics (April 2011)


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

Key Points


New drugs

FDA has approved ProStrakan's Abstral (fentanyl transmucosal immediate-release tablets, in 100 μg, 200 μg, 300 μg, 400 μg, 600 μg, and 800 μg dosage strengths) for management of breakthrough pain in adult patients with cancer who already use opioid pain medication around the clock and who need high doses of an additional opioid medication. ( / 908-234-1096)

FDA has approved Depomed's Gralise (gabapentin tablets) for the once-daily treatment of post-herpetic neuralgia (PHN). Gralise will be available later this year in 300 mg and 600 mg dosage strengths. ( / 866-458-6389)

Sunovion's Latuda (lurasidone HCl), a once-daily atypical antipsychotic treatment for adult schizophrenia patients, is now available in 40 mg and 80 mg tablet strengths in pharmacies across the United States. (

FDA has approved Clinical Data's Viibryd (vilazodone HCl tablets in 10 mg, 20 mg, and 40 mg strengths), a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist, to treat major depressive disorder. ( / 617-527-9933)

Avanir's Nuedexta (20 mg dextromethorphan hydrobromide/10 mg quinidine sulfate capsules) is now available to treat pseudobulbar affect, a neurologic condition causing involuntary, sudden, and frequent episodes of laughing and crying in patients with certain underlying neurologic diseases or injuries. ( / 855-468-3339)

New generic

FDA has granted final approval for Hi-Tech Pharmacal's ANDA for levofloxacin ophthalmic solution 0.5% (generic for Vistakon's Quixin ophthalmic solution). (888-855-7919)

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