• Progesterone vaginal gel 8% (Watson Pharmaceuticals and Columbia Laboratories) for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy. The complete response letter (CRL) stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at ≤32 6/7 weeks gestation (P=.022) did not meet the level of statistical significance generally expected to support the approval of the product in the US market from a single trial. Although not part of the requirements communicated to the sponsor during pre-phase 3 meetings, FDA also raised the issue of robustness in efficacy in the US sub-cohort as compared to the overall efficacy of the trial. In the CRL, FDA stated that additional clinical work would be required to support the approval. Watson said it will work directly with FDA to address items raised in the CRL regarding the approvability of progresterone vaginal gel 8% for reduction of preterm birth. It has formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application.
• Decitabine (Dacogen, Eisai) for the treatment of acute myeloid leukemia (AML) in adults aged 65 years or older who are not considered candidates for induction therapy. FDA declined to approve the application because it said that the primary study (DACO-016) did not provide convincing evidence of safety and effectiveness for the proposed AML indication.
• Ezetimibe/atorvastatin tablets (Merck) for the treatment of high cholesterol. FDA advised Merck that additional data are needed. Merck plans to discuss next steps with FDA, including new data expected to be available later this year.
Recommended for approval
• Oral, controlled-release formulation of low-dose phentermine and topiramate (Qnexa, Vivus) for the treatment of obesity in adults.
• Droxidopa (Northera, Chelsea Therapeutics) for treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta hydroxylase deficiency, and non-diabetic autonomic neuropathy.
• Rivaroxaban (Xarelto, Janssen) for the reduction of risk of thrombotic cardiovascular events in patients with acute coronary syndrome.
• Clinical development program of Viaskin Peanut (DBV Technologies), a product designed for the treatment by epicutaneous immuotherapy of patients with peanut allergy.
First-time generic approvals
Escitalopram Oxalate Oral Solution, in 5 mg/5 mL strength liquid form (equiv to Lexapro) AMNEAL PHARMACEUTICALS
Escitalopram tablets USP, 5 mg, 10 mg, and 20 mg (equiv to Lexapro) TEVA/IVAX PHARMACEUTICALS
Ziprasidone hydrochloride capsules, 20-mg, 40-mg, 60-mg, and 80-mg strengths (equiv to Geodon) DR REDDY'S
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