Drugs
FDA commissioner Scott Gottlieb says that opioid addiction often starts with a prescriber’s pen and the number of prescriptions being written is too high. “The doses of opioids being prescribed are also high, and we know that the higher the daily dose, the greater the chance of misuse, overdose,
Drugs
The 3rd Circuit Court of Appeals has reiterated the notion that evidence of an actual false claim is necessary for a False Claims Act suit to succeed. Attorneys Kristin Koehler and Joshua Fougere (Sidley Austin) write in a Washington Legal Foundation Legal Opinion Letter that the 3rd Circuit ruling “should
Drugs
FDA has accepted for priority review two Paratek Pharmaceuticals NDAs for omadacycline, an investigational once-daily oral and intravenous broad spectrum antibiotic. The company says it is seeking approval of omadacycline, a modernized tetracycline, for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)
Drugs
FDA has accepted an Antares Pharma NDA resubmission for Xyosted (testosterone enanthate) injection for testosterone replacement therapy. The NDA received a 10/2017 complete response letter that identified two deficiencies related to clinical data, according to the company. “Based on findings in studies QST-13-003 and QST-15-005,
Drugs
FDA has released a guidance, Liposome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation, to cover what types of information applicants should submit in NDAs or ANDAs for a liposome drug product reviewed by CDER. The document finalizes a 10/2015 draft. The agency says
Drugs
FDA says that benefit-risk assessment is a fundamental element of the agency’s drug regulatory decision-making, and both the agency and stakeholders continue to see value in FDA’s Benefit-Risk Framework (BRF) as a tool to support internal agency decision making, improve communication to internal and external
Drugs
FDA has released the FDA-483 containing 11 observations issued following a 2/12-3/5 inspection at SCA Pharmaceuticals, Windsor, CT. Specific observations were: * the written stability program for drug products does not include reliable and meaningful test methods; * procedures designed to prevent microbiological contamination of drug products purporting
Drugs
University of Pittsburgh researchers say that cancer drugs are approved faster in the U.S. than in overseas countries. The study was reported in the Journal of Managed Care & Specialty Pharmacy. The researchers looked at 45 oncology drugs approved by FDA between 2009 and 2013. They found that most
Drugs
The Justice Department says Gao Mei Fang (also known as Amy Gao), of Shanghai, China, pleaded guilty to mail fraud and smuggling charges in connection with a scheme to sell mislabeled dietary supplements. An agency news statement says Gao was the supply chain manager for Genabolix USA and Shanghai Yongyi
Drugs
FDA has granted Proteostasis Therapeutics a fast track designation for its triple combination product for cystic fibrosis, consisting of cystic fibrosis transmembrane conductance regulator (CFTR) modulators known as PTI-428, PTI-801 and PTI-808. All three drug candidates were discovered internally at the company and are “designed to act
Drugs
FDA has accepted for priority review a Pfizer NDA for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations. The European Medicines Agency has also accepted an
Drugs
Endo says it has agreed to extend a temporary stay of its litigation against FDA seeking a court declaration that the agency’s interim policy on compounding using bulk drug substances under Section 503B of the Drug Quality and Security Act of 2013 (DQSA) is contrary to law because it
Drugs
FDA has released the establishment inspection report from its 5/22-6/2/17 inspection at the Celltrion Yeonsgu-go Plant 1, Inchon City, Korea. The report says the inspection found that the firm continues to manufacture a drug substance, Inflectra (infliximab-dyyb), for the U.S. market as well
Drugs
FDA has ordered a mandatory recall of all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmaceuticals. An agency media statement says the recall was ordered after several products were found to contain salmonella and the company failed to cooperate with an FDA request for a
Drugs
Several drug companies are asking the Supreme Court to resolve differences between Circuit Courts of Appeals on the question of whether consumers who think they might have paid less for treatment if a drug product were packaged differently is sufficient to establish an economic injury that can be subject of
Drugs
Several stakeholder groups have submitted comments thanking FDA for its three public meetings on implementation of the Drug Supply Chain and Security Act (DSCSA) and suggesting improvements to the program. The American Society of Healthsystem Pharmacists asked the agency to consider its recommendations on stakeholder engagement, hospital- and health system-
Drugs
FDA has approved an AstraZeneca NDA for Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with Type 2 diabetes with inadequate glycemic control. The expanded use is based on data from the 28-week DURATION-7 study, which examined the effect
Drugs
FDA and the International Medication Safety Network have announced a 6/19-20 international summit on medication safety issues. “To achieve a reduction of overall harm related to medication errors, harmonization at the global level is desirable,” an FDA notice says. Product container labeling, and packaging issues are common among
Drugs
U.S. Senators Susan Collins (R-ME), Claire McCaskill (D-MO), and Catherine Cortez Masto (D-NV) have sent a letter to Tri-Source Pharma CEO Robert DiCrisci, asking for an explanation on why a 40-year-old, off-patent cancer drug, lomustine, has experienced a recent price increase of
Drugs
Promius Pharma, a Dr. Reddy’s Laboratories subsidiary, has filed an NDA New for its migraine candidate DFN-02, an intranasal formulation of sumatriptan 10 mg and Aegis Therapeutics’ permeation-enhancing technology known as Intravail. “This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation,
Drugs
FDA has issued Alkermes a Refusal to File letter on its NDA for New ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. According to the company, FDA said it
Drugs
Vertice Pharma has petitioned FDA to revise and make more stringent bioequivalence requirements outlined in its “Draft Guidance for Sucralfate Oral Suspension.” In the petition, the company asks the agency to “remove the requirement that a generic sucralfate oral suspension formulation must be both qualitatively and quantitatively the same as