Dec
17
to Dec 18

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The committees will provide input and advice on strategies to increase the availability of naloxone products intended for use in the community. The committees will be asked to consider various options for increasing access to naloxone, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the committees will also be asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients. 

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Nov
14
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The committees will discuss a new drug application for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will also be asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved.

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Nov
2
8:00 AM08:00

Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

The committees met jointly to discuss the efficacy, safety, and benefit-risk profile of a new drug application for Zulresso (brexanolone) 5 mg/mL intravenous injection, submitted by Sage Therapeutics (Sage), for the proposed indication of postpartum depression (PPD). The joint committee voted nearly unanimously (17 of 18 membersr) in favor of recommending approval.

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Nov
1
to Nov 2

Advisory Committee on Heritable Disorders in Newborns and Children

The committee heard from experts in the field and discuss issues related to newborn screening information, education, training activities, and training resources. The committee also heard presentations on the use of genomic sequencing in newborn screening as well as the clinical setting for both well and sick infants. In addition, the committee discussed the nomination of cerebrotendinous xanthomatosis (CTX) to the RUSP.

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Nov
1
8:00 AM08:00

Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

The joint committee met to discuss the efficacy, safety, and risk-benefit profile of the new drug application (NDA) for ALKS-5461 (buprenorphine and samidorphan sublingual tablets), submitted by Alkermes, Inc. (Alkermes), for adjunctive treatment of major depressive disorder (MDD).

A majority of the joint committee, 21 of 23 members, voted that the available data do not support a favorable benefit-risk profile of ALKS-5461 to support its approval. Two of 23 joint committee members voted that the available data do support its approval.

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Oct
24
to Oct 25

Endocrinologic and Metabolic Drugs Advisory Committee

The committee discussed the cardiovascular risk assessment of drugs for the treatment of type 2 diabetes mellitus and related FDA guidance (“Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes” (2008)).

A narrow majority of the committee, 10 of 19 members, voted that an unacceptable increase in cardiovascular risk should be excluded for all new drugs to improve glycemic control in patients with type 2 diabetes, regardless of the presence or absence of a signal for cardiovascular risk in the development program.

A narrow minority of the committee, 9 of 19 members, voted that an unacceptable increase in cardiovascular risk should not be excluded for all new drugs to improve glycemic control in patients with type 2 diabetes, regardless of the presence or absence of a signal for cardiovascular risk in the development program.

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Oct
22
9:00 AM09:00

Science Board to FDA

The SBFDA heard a response from the Center for Veterinary Medicine (CVM) to the recommendations made by the Science Board’s 2017 review of CVM’s National Antibiotic Resistance Monitoring System (NARMS) program. The Science Board also discussed potential hazards and nutritional considerations in the production of food derived from animal cell culture technologies. 

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Oct
18
8:00 AM08:00

Gastrointestinal Drugs Advisory Committee

The committee met to discuss a new drug application (NDA) for Motegrity (prucalopride) tablets for oral administration, submitted by Shire Development, LLC (Shire), proposed for the treatment of chronic idiopathic constipation in adults.

The committee voted unanimously (10 of 10 members) that the clinical trial data provide substantial evidence of effectiveness of prucalopride for the treatment of adults with chronic idiopathic constipation (CIC).

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Oct
17
8:00 AM08:00

Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

The committee met to discuss a supplemental new drug application (sNDA) for Zelnorm (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch (Sloan). Note that the Investigational New Drug (IND) application for Zelnorm was transferred from its initial holder, Novartis, to Sloan on November 24, 2015, and US World Meds, LLC is acting as an authorized agent for Sloan on the sNDA.

A majority of the Committee, 7 of 12 members, voted that “IBS-C females at low CV risk” is the patient population in whom they would expect the benefits to outweigh the risks. Three of 12 members voted that “IBS-C females at low CV risk and who are severely symptomatic” is the patient population in whom they would expect the benefits to outweigh the risks. One committee member voted that “IBS-C females,” with no qualification for CV risk, is the patient population in whom the benefits are expected to outweigh the risks. He elaborated that although the indication should be kept broad, labeling should include information about the both safety signals to guide prescribing. One Committee member voted for “other” because she felt the appropriate population is IBS-C females at low CV risk who are severely symptomatic and who are also at low psychiatric risk.

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Oct
12
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee

The committee met to discuss the resubmission of a new drug application (NDA) by AcelRx Pharmaceuticals, Inc. (AcelRx) for DSUVIA (sufentanil sublingual tablet 30 mcg), proposed for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients, in a medically supervised setting. The committee was asked to discuss risk-benefit considerations and whether this product should be approved.

A majority of the committee, 10 of 13 members, voted that the benefits of DSUVIA, with the Risk Evaluation and Mitigation Strategies (REMS) proposed by the FDA, outweigh the risks for the proposed moderate-to-severe pain indication, supporting its approval.

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Oct
11
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee

The committee met to discuss a new drug application (NDA) for oliceridine (0.1 mg/milliliter and 0.35 mg/milliliter), submitted by Trevena, Inc. (Trevena), proposed for the management of moderate-to-severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted. The committee was asked to discuss the efficacy and safety data and benefit-risk considerations.

A narrow majority of the committee, 8 of 15 members, recommended that the FDA should not approve oliceridine for the proposed management of moderate-to-severe acute pain in adults for whom an IV opioid is warranted.

 

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Oct
10
8:00 AM08:00

Oncologic Drugs Advisory Committee

The committee discussed the resubmission of a biologics license application (BLA) for CT-P10, a proposed biosimilar of Rituxan (rituximab) by Celltrion, Inc. (Celltrion). Pending licensure, Teva Pharmaceutical Industries, Ltd is responsible for all commercial activities of CT-P10 in the US.

The committee voted unanimously (16 of 16 member) that the totality of the evidence support the licensure of CT-P10 as a biosimilar product of Rituxan for the following three indications:

·      relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non–Hodgkin’s Lymphoma (NHL) as a single agent;

·      previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and

·      non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

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Sep
20
8:00 AM08:00

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

The committee discussed and voted on two topics related to the Office of Pharmaceutical Quality's priority of promoting the availability of better medicine. The first topic was the modernization of generic drug applications through a Knowledge-aided Assessment & Structured Application (KASA) initiative. The committee members were unanimous, by a vote of 10-Yes to 0-No, with no abstentions, in their support of the development of a structured application as a part of the KASA initiative. The second topic involved the establishment of patient focused quality standards for extended-release solid oral drug products. The committee members were unanimous, by a vote of 11-Yes to 0-No, with no abstentions, in their recommendation that the FDA establish patient-focused dissolution standards for extended-release solid oral dosage forms. Note that one of the members of the committee attended and voted only in the Topic II session.

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Sep
20
8:00 AM08:00

Pediatric Advisory Committee

The committee heard pediatric-focused safety reviews for Intuniv (guanfacine) and Lexapro (escitalopram). For each of these drugs, the committee voted in favor, by a vote of 11-Yes and 1No, of the monitoring proposed by the FDA’s Division of Pharmacovigilance (DPV). For Intuniv, the DPV proposed to continue monitoring for adverse events (AEs), including suicidal ideation and behavior, pancreatitis, and medication error involving name confusion. For Lexapro, the DPV proposed to continue routine safety monitoring

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Sep
12
8:00 AM08:00

Pharmacy Compounding Advisory Committee

The Committee agreed unanimously with the FDA’s recommendation to include the following four bulk drug substances on the list of bulk substances allowed for compounding: alpha lipoic acid (solid oral dosage); coenzyme Q10 (for oral administration); creatine monohydrate (solid oral dosage forms); and pyridoxal 5 phosphate (intravenous and oral dosage forms).

The Committee agreed unanimously with the FDA’s recommendation to exclude quercetin dihydrate on the list of bulk substances allowed for compounding.

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Aug
8
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed new drug applications (NDAs) for omadacycline tablets and injection, sponsored by Paratek Pharmaceuticals, Inc. (Paratek), for the proposed indications for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

A majority of the Committee, 17 of 18 members, voted that Paratek has provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

A majority of the Committee, 14 of 18 members, voted that Paratek has also provided evidence of the safety and effectiveness of omadacycline for the treatment of community acquired bacterial pneumonia (CABP).

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Aug
7
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed a new drug application (NDA) for amikacin liposome inhalation suspension (ALIS), sponsored by Insmed, Inc. (Insmed), for the proposed indication of treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults, as part of a combination antibacterial drug regimen.

A majority of the Committee, 12 of 14 members, voted that Insmed has provided substantial evidence of the effectiveness and sufficient evidence of the safety of ALIS for the treatment of nontuberculous mycobacterial lung disease caused by MAC, as part of a combination antibacterial drug regimen, for adult patients with limited or no treatment options. A same majority of the Committee, 12 of 14 members, did not support broader use for all adult patients with the disease.

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Jul
26
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed a new drug application (NDA) for tafenoquine tablets, sponsored by 60 Degrees Pharmaceuticals, LLC (60 Degrees), for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing.

A majority of the Committee, 11 of 13 members, voted that 60 Degrees has provided substantial evidence of the effectiveness of tafenoquine for the proposed use.

A slightly lesser majority of the Committee, 9 of 13 members, voted that 60 Degrees has provided adequate evidence of the safety of tafenoquine for the proposed use.

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Jul
25
8:00 AM08:00

Pulmonary and Allergy Drugs Advisory Committee

The Committee discussed a supplemental biologics license application (sBLA) for Nucala (mepolizumab), by GlaxoSmithKline (GSK), which proposed use as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts.

·      A majority of the Committee, 16 of 19 members, voted that the benefit-risk profile is not adequate to support approval of mepolizumab for the proposed use.

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Jul
18
to Jul 19

Blood Products Advisory Committee

On the first day of the meeting, the Committee will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day of the meeting, the Committee, supplemented with members from the Microbiology Devices Panel of the Medical Devices Advisory Committee, will function as a medical device panel to provide advice and recommendations to the Agency on classification of devices.

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Jul
12
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee voted unanimously (13 of 13 members) that GSK has provided substantial evidence of the effectiveness of tafenoquine for the radical cure (prevention of relapse) of P. vivax malaria in patients 16 years of age and older. T

A majority of the Committee, 12 of 13 members, voted that GSK has provided adequate evidence of the safety of tafenoquine for the proposed use.

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Jun
26
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

A majority of the joint Committee, 14 of 17, voted to recommend against the approval of Pain Therapeutics’ Remoxy ER (oxycodone extended-release capsules).
The proposed indication of Remoxy ER is the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have properties that deter abuse by the intranasal and intravenous routes of abuse, based on physicochemical properties of its formulation.

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Jun
22
8:00 AM08:00

Blood Products Advisory Committee

In the morning open session, under Topic 1, the Committee will hear presentations on the research programs in the Laboratory of Emerging Pathogens (LEP), Laboratory of bacterial and TSE Agents (LBTSE), and from the Laboratory of Molecular Virology (LMV) in the Division of Emerging Transfusion-Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), FDA. After the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). In the afternoon, in open session, under Topic II, the Committee will hear presentations on the research program in the Hemostasis Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), FDA. After the open session, the meeting will be closed to the public to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6).

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Jun
20
8:00 AM08:00

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

The Committee reviewed and discussed a list of molecular targets for which evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and a list of those targets deemed unlikely to be associated with the growth or progression of pediatric tumors.

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