Drugs
FDA says that Merck has failed to meet its Pediatric Research Equity Act (PREA) study requirement for Cubicin (daptomycin for injection) that was due 8/31/15. In a 3/3 letter to the company, the agency notes that Merck had requested a deferral extension and that FDA had determined
Drugs
Eagle Pharmaceuticals is asking the DC federal court to order FDA to grant seven-year orphan drug exclusivity for its Bendeka (bendamustine HCl), an IV chemotherapy agent. The suit says that the agency granted Bendeka orphan drug designation 7/2/14 and approved it 12/7/15. However, it denied
Drugs
FDA and industry negotiations for Biosimilars User Fee Act 2 reauthorization started considering 3/31 an agency application review enhancement proposal based on a model followed by CDER under the Prescription Drug User Fee Act. Meeting minutes show that agency representatives said that such a model could promote the efficiency
Drugs
FDA has granted Novartis three breakthrough therapy designations for Ilaris (canakinumab) to treat three rare types of Periodic Fever Syndromes, which are also known as Hereditary Periodic Fevers. The autoinflammatory diseases cause disabling and recurrent fevers, which may be accompanied by joint pain and swelling, muscle pain and skin rashes.
Drugs
FDA has granted Therabron Therapeutics fast track status for rhCC10 (recombinant human club cell 10 kDa protein) and its use in preventing chronic lung disease related to premature birth. The company says the investigational drug has potent anti-inflammatory properties for a variety of respiratory diseases. The drug is currently
Drugs
FDA has accepted for review an OPKO Health NDA resubmission for Rayaldee (calcifediol) for treating secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The filing addresses a 3/29 complete response letter (CRL) that indicated the NDA could not be approved due
Drugs
Rep. Sean Maloney (D-NY) has introduced the Opioid Review Modernization Act of 2016 (H.R. 4976) to require FDA to seek advisory committee recommendations before approving opioids without abuse-deterrent properties. The bill also would create a strategy for educating doctors on the potential harms in overprescribing opioids. “No
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the current legal/enforcement situation regarding off-label promotion of drugs and medical devices has little to commend it. Writing in an online Update, Shapiro says that the status quo “does not respect the First Amendment rights of device and drug
Drugs
Pfizer subsidiary Wyeth has agreed to settle allegations that between 2001 and 2006 it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program for the sales of Protonix oral and Protonix IV. Under the settlement, Wyeth will pay a total of $785 million to the federal government and individual
Drugs
FDA has extended by three months its review of a Dynavax Technologies BLA for Heplisav-B, an investigational vaccine for immunizing adults against Hepatitis B infection. Earlier this month, the company submitted FDA-requested individual trial data sets that had earlier been provided as integrated data. The agency has now
Drugs
Some 75 members of the House and Senate from both parties are expressing concern that FDA has loosened standards governing use of the abortion drug Mifeprex, also known as RU-486. In a 4/25 letter to FDA commissioner Robert Califf, the lawmakers say that the drug’s original approval
Drugs
Chinese laboratories are producing and openly selling a new form of fentanyl to get around that country’s export laws and the fact that it is not yet on the U.S. government list of controlled substances. Stat News reports that furanyl fentanyl, which was blamed for the March overdose
Drugs
FDA says it believes that most issues identified by clozapine manufacturers when the drug’s REMS (Risk Evaluation and Mitigation Strategy) program was first implemented in 2015 have been resolved. In a post-market drug safety report, the agency says it is continuing to work with manufacturers to develop a
Drugs
FDA has issued Otsuka Pharmaceutical Co. and Proteus Digital Health a complete response letter for their Digital Medicine, a drug/device combination product that combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in the tablet. The NDA was submitted as a system
Drugs
A 3/16-23/15 FDA inspection at Polydrug Laboratories, Mumbai, India, found significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients. A 4/14 Warning Letter says that specific deviations included: * failing to record and investigate all quality-related customer complaints according to
Drugs
FDA has told Catalyst Pharmaceuticals that it will need positive results from an additional study of the company’s Firdapse (amifampridine phosphate) in patients with Lambert-Eaton myasthenic syndrome (LEMS) before the agency will accept Catalyst’s NDA for filing. FDA told the company that it is open to discuss
Drugs
FDA says it is evaluating the results of a Danish study that concluded there is a possible increased risk of miscarriage with use of oral fluconazone (Diflucan) for yeast infections. An agency safety communication says it also is reviewing additional data and will communicate final conclusions and recommendations when the
Drugs
FDA has released a list of Medication Guides including three new and 10 updated guides. New guides were released for Aciphex DR (rabeprazole sodium) delayed-release capsules; Pfizer’s Inflectra (infliximab), and Genentech’s Venclexta (venetoclax) tablets. Updated guides were released for Aciphex (rabeprazole sodium), Takeda’s Kazano (alogliptin benzoate
Drugs
Six stakeholder organizations, including industry and public health groups, say they will contact lawmakers and their staffs 4/27 urging funding for full implementation of the new federal drug compounding law. A letter to be sent says that on 4/18 the House Appropriations Committee passed an agricultural spending bill
Drugs
FDA has approved a Collegium Pharmaceutical NDA for Xtampza ER (oxycodone) extended-release capsules, a twice-daily medication for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Xtampza uses the company’s proprietary DETERx technology platform,
Drugs
FDA has approved an AstraZeneca NDA for Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol, indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. The product is not indicated for treating asthma or for relieving acute bronchospasm.
Drugs
Believing from media reports that FDA is nearing a decision on its proposal to amend regulations governing procedures for application holders of an approved drug or biologic product to make unilateral changes in the product labeling, Washington Legal Foundation has reiterated its objection to the proposal and its support for