Drugs
FDA has approved an Elite Pharmaceuticals ANDA for a generic version of Shire’s Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate) in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets. The central nervous system stimulant is indicated for treating attention deficit
Drugs
On a near party-line 230-192 vote with only two Republicans joining all Democrats, the House approved 12/12 H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. It now goes to the Senate where it will face significant opposition. President Donald Trump has already said
Drugs
Provention Bio says that as a result of a meeting with FDA staff to discuss the proposed contents of a BLA for its PRV-031 (teplizumab) for prevention or delay of Type 1 diabetes in at-risk individuals, it expects to open a rolling BLA submission mid-2020 and complete
Drugs
FDA has released for comment a draft guidance, FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, to address early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact (brivaracetam) oral solution and separately for an injectable formulation. The oral solution is indicated for adjunctive therapy in treating partial-onset seizures in patients 16 years of age and older with epilepsy, whereas the
Devices
FDA has cleared a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant. The device uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea), the company says. “The
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Alkermes print ad for Vivitrol (naltrexone for extended-release injectable suspension) for intramuscular use is false and misleading because it omits important risk information associated with using the drug. A 12/2 Warning Letter says the violation “is concerning from
Drugs
FDA has accepted for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. The submission is based on results from the Phase 3 POLYP 1 and POLYP 2 trials, which showed Xolair
Drugs
The Senate voted 12/10 to approve on a 91-2 vote S. 2740, the Over-the-Counter Drug Safety, Innovation, and Reform Act, which its sponsors say will streamline and modernize FDA’s regulatory system. A statement from Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) says
Drugs
FDA’s Cardiovascular and Renal Drug Advisory Committee has voted 11-2 against recommending approval of Correvio Pharma’s vernakalant for use to rapidly convert recent onset atrial fibrillation to sinus rhythm. Panel members were concerned about safety issues, which included bradycardia, ventricular arrhythmias and deaths recorded in clinical trials.
Devices
FDA has cleared an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition. Previously, the device was cleared as an aid in the early detection of secondary lymphedema, and determining fluid status for patients living with heart failure. The expanded clearance permits Sozo
FDA Policy/General
A recent DC federal court decision in a Centers for Medicare and Medicaid Services (CMS) case could be followed to a conclusion that courts may see FDA Warning Letters as final agency action. Attorney Michelle Yeary (Dechert) says in an online Drug and Device Law post that the case involved
Drugs
The Council for Responsible Nutrition (CRN), which represents dietary supplement and functional food manufacturers, says it applauds a Supreme Court decision not to hear an Amrin Pharma appeal of a lower court ruling in a fish oil case. In a statement, CRN says the decision “maintains FDA’s proper jurisdiction
Drugs
FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, TN have been recalled. In September, a federal court approved a consent decree (see story) against the firms for unlawfully distributing the products. Products that have been recalled include drugs
Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says Congress may be readying a “significant blow” to the Waxman-Hatch Act and the generic drug industry through passage of the Lower Health Care Costs Act of 2019. In a post in his firm’s FDA Law Blog, Karst says the bipartisan,
Drugs
BIO president Jim Greenwood is criticizing the Trump administration and House Speaker Nancy Pelosi for surrendering a “powerful tool for reining in foreign free riding.” In a statement on the apparent agreement on the USMCA trade pact with Mexico and Canada, Greenwood said the renegotiated pact eliminates provisions that prohibit
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) have written to acting FDA commissioner Brett Giroir asking for the status of proposed rules on over-the-counter hearing aids. In a 12/5 letter, Grassley and Warren note that President Donald Trump signed the Over-the-Counter Hearing
Biologics
Verax Biomedical is asking that FDA: * refrain from clearing, approving, recommending, or issuing a “safety measure” designation for large volume delayed sampling (LVDS) as a single step bacterial culture technology for dating beyond Day 5 without first obtaining statistically conclusive data supporting the safety and effectiveness from clinical evidence on
Biologics
A report by the Alliance for Cell Therapy Now says there is a need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for National Institutes of Health research and expanded capacity at FDA to support the rapidly growing field. The
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Rempex Pharmaceuticals’ Vabomere (vaborbactam and meropenem), indicated for treating patients 18 years and older with complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria. The regulatory review period has been determined to be
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0605). FDA’s regulations specify the criteria and procedures for requesting MUMS designation as well as
Drugs
A 4/22-5/20 FDA inspection at Teligent Pharma, Buena, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/26 Warning Letter says the inspection also revealed that the firm failed to submit NDA field alert reports as required by law and