FDA Actions in Brief July 2011 (Oxecta, Creon, Lupron Depot, Nulojix, Zutripro Oral Solution, Potiga, Solesta, Dificid, Istodax, Rectiv, IaViv)

July 1, 2011

Recent FDA Approvals (through June 2011) related to Oxecta, Creon, Lupron Depot, Nulojix, Zutripro Oral Solution, Potiga, Solesta, Dificid, Istodax, Rectiv, IaViv

Immediate-release version of oxycodone (Oxecta, Pfizer and Acura) was approved for the treatment of acute or moderate-to-severe pain designed to prevent drug tampering and misabuse.

An infant-specific dose of pancrelipase (Creon, Abbott) delayed-release capsules was approved to treat exocrine pancreatic insufficiency due to cystic fibrosis. The FDA-approved class is the Creon 3,000 units of lipase capsule that provides the lowest dosage strength.

A 45 mg for 6-month administration formulation of leuprolide acetate for depot suspension (Lupron Depot, Abbott), was approved for the palliative treatment of advanced prostate cancer.

Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephendrine HCl (Zutripro Oral Solution (CIII), Cypress Pharmaceuticals) and hydrocodone bitartrate and pseudoephedrine HCl (Rezira Oral Solution (CIII), Cypress Pharmaceuticals) were approved for the relief of cough and symptoms associated with the common cold.

Ezogabine (Potiga, Valeant and GlaxoSmithKline) potassium channel opener was approved as an adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

Sterile, injectable gel (Solesta, Oceana Therapeutics) was approved to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy, or antimotility medications failed.

Fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets were approved for the treatment of Clostridium difficile-associated diarrhea.

Romidepsin for injection (Istodax, Celgene) was granted expanded approval to treat peripheral T-cell lymphoma in patients who have received at least 1 prior therapy. Istodax is also approved for treating cutaneous T-cell lymphoma in patients who have received at least 1 prior systemic therapy.

Nitroglycerin (Rectiv Ointment, ProStrakan) 0.4% was approved for the treatment of moderate-to-severe pain associated with chronic anal fissures.

Azficel-T personalized aesthetic cell therapy (laViv, Fibrocell Science) was approved for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles (smile lines) in adults.

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