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Complete response

Fluocinolone acetonide intravitreal implant (Iluvien, Alimera) for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficently responsive to available therapies. Identifying concerns regarding the benefit to risk and safety profiles of Iluvien, FDA stated in the complete response letter (CRL) that the NDA could not be approved in its present form. To address the clinical and statistical deficiencies identified, FDA indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients. FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee may be of assistance in addressing the deficiencies identified above and providing advice whether a patient population can be identified in which the benefits of the drug product might outweigh the risks. In a separate written communication from the staff of FDA, Alimera was notified that an Advisory Committee meeting would be convened on January 27, 2014. In the CRL, FDA also referenced deficiencies at the facility where Iluvien is manufactured. Alimera does not believe that these deficiencies will affect its European commercial supply.

Priority review

Ramucirumab (IMC-1121B) (Eli Lilly) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

Fast-track designation

ALKS 5461 (Alkermes) for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard therapies.

Orphan drug designations

Z160 (Zalicus) first-in-class, oral, state-dependent, selective N-type calcium channel for the management of postherpetic neuralgia.

CRS-207 (Aduro BioTech), a novel immunotherapy, for the treatment of pancreatic cancer.

Bacteroides thetaiotaomicron (Thetanix, GT Biologics) for pediatric Crohn’s disease.

CPI-613 (Cornerstone Pharmaceuticals) altered energy metabolism directed drug candidate for treatment of myelodysplastic syndrome.

Ublituxiumab (TG-1101) (TG Therapeutics) novel, glucoengineered anti-CD20 monoclonal antibody for the treatment of nodal marginal zone lymphoma and extranodal marginal zone lymphoma, rare subtypes of non-Hodgkin’s lymphoma.

First-time generic approvals

Paricalcitol capsules (equiv to Zemplar)


Tobramycin Inhalation Solution USP (equiv to TOBI)


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