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Complete response

◾ Rintatolimod (Ampligen, Hemispherx Biopharma) for chronic fatigue syndrome (CFS). FDA said Hemispherx should conduct at least 1 additional clinical trial, complete various nonclinical studies, and perform a number of data analyses. In the complete response letter (CRL), FDA set forth the reasons for this action and provided recommendations to address certain outstanding issues. FDA stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. Hemispherx plans to request an end-of-review conference with FDA as a precursor to submitting a formal appeal to the Office of New Drugs in FDA’s Center for Drug Evaluation and Research regarding the Agency’s decision.

◾ Insulin degludec (Tresiba, Novo Nordisk) and insulin degludec/insulin aspart (Ryzodeg, Novo Nordisk) for the treatment of diabetes. In the CRL, FDA requested additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the CRL and will work closely with FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during 2013. In the letter, FDA also states that approvals for Tresiba and Ryzodeg cannot be granted until the violations cited in the previously announced warning letter, dated December 12, 2012, have been resolved.

Priority review

◾ Dolutegravir (GlaxoSmithKline and ViiV) for the treatment of HIV/AIDS.

◾ Radium-223 dichloride (radium-223, Bayer HealthCare) for the treatment of castration-resistant prostate cancer patients with bone metastases.

Orphan drug designations

◾ APG101 (Apocept, Apogenix GmbH), a first-in-class, fully human fusion protein combining the extracellular domain of the CD95 receptor and the Fc portion of IgG, for the treatment of myelodysplastic syndromes.

◾ LG631-CD34 (Lentigen) for bone marrow protection in the treatment of glioblastoma multiforme.

◾ PLacental eXpanded (PLX) cells (Pluristem Therapeutics) for the treatment of aplastic anemia.

◾ First-time generic approvals

Buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets in 2-mg/0.5-mg and 8-mg/2-mg strengths (equiv to Suboxone) amneal pharmaceuticals

Doxorubicin hydrochloride liposome injection (equiv to Doxil) sun pharma global

Clindamycin in 5% dextrose (equiv to Cleocin Phosphate in Dextrose 5%) sandoz

Mixed salts of a single-entity amphetamine in 5-mg, 15-mg, 20-mg, 25-mg, and 30-mg capsules (equiv to Adderall) teva