Devices
FDA has cleared an electroCore 510(k) for an expanded label for gammaCore as an acute treatment of pain associated with migraine in adult patients. The neuromodulation treatment is delivered by a hand-held unit that stimulates the vagus nerve through the skin. It was initially cleared 4/2017 for
Drugs
FDA has issued Aradigm a complete response letter (CRL) on its NDA for Linhaliq (liposomal ciprofloxacin for inhalation) as a treatment for non-cystic fibrosis bronchiectasis patients with chronic Pseudomonas aeruginosa (P. aeruginosa) lung infections. The letter says the NDA cannot be approved in its present form, and provides recommendations
FDA Policy/General
Sanofi has agreed to buy Belgium-based Ablynx for $4.8 billion. Ablynx focuses on Nanobodies, a novel class of next-generation biologics. The company has a pipeline of more than 45 proprietary and partnered drug candidates for treating hematology, inflammation, immuno-oncology and respiratory diseases. Casi Pharma has acquired
FDA Policy/General
Regulatory Review Period Determined for Vraylar Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Forest Labs Vraylar (cariprazine) to be 3,742 days. 01/26/2018 Regulatory Review Period Determined for Varubi Federal Register notice: FDA determines for patent extension purposes the regulatory review
Devices
CDRH has posted review metrics for its Accredited Persons Program for 510(k)s. The metrics are mandated by the device user fee program. According to the report, 18 third-party 510(k)s have been reviewed. The average total time from receipt of a 510(k) to a final
Drugs
FDA has approved an Advanced Accelerator Applications NDA for Lutathera (lutetium Lu 177 dotatate) for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency says this is the first radiopharmaceutical approved for treating the tumors. The drug works by binding to a part of a cell called a somatostatin receptor, which
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Forest Labs Vraylar (cariprazine) to be 3,742 days. Of this time, 2,709 days occurred during the testing phase and 1,033 days occurred during the approval phase. Vraylar is indicated for treating schizophrenia
Drugs
FDA has tentatively approved a Perrigo ANDA for a generic version of Valeant Pharmaceutical’s Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%), indicated for topical treatment of acne vulgaris in patients 12 years of age and older. Branded market sales for the last 12 months were
Drugs
The Washington DC District Court has remanded to FDA an Amgen lawsuit against the agency over its denial to grant pediatric exclusivity for the company’s Sensipar (cinacalcet hydrochloride). In its complaint, Amgen argued that FDA’s decision to grant an earlier pediatric exclusivity award to Johnson & Johnson’s
FDA Policy/General
FDA commissioner Scott Gottlieb has ordered the termination of an agency-sponsored animal (monkey) study of nicotine exposure over inhumane treatment concerns. Four monkeys died and now the remaining animals have been placed in a permanent sanctuary home. Gottlieb said that an internal review team “will determine the safety and
Devices
FDA has approved a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system. The assay offers a unique, dual-target approach that delivers “accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome,” the
Drugs
FDA has cleared a Hitachi 510(k) for its Real Time Image Gating System for Proton Beam Therapy Systems” for treating cancer patients. The device uses proprietary technology to track and irradiate tumors in motion. “This is accomplished by positioning a gold marker 2mm in diameter, close to the tumor
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for OPKO Health’s Varubi (rolapitant) to be 3,070 days. Of this time, 2,708 days occurred during the testing phase and 362 days occurred during the approval phase. Varubi is indicated in combination with
FDA Policy/General
Federal Register notice: FDA has announced that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee has been renewed for an additional two years beyond the charter expiration date. The new charter will be in effect until 1/22/2020. To view the notice, click here.
FDA Policy/General
Federal Register direct final rule: FDA is amending its general biologics regulations covering time of inspection and duties of inspector requirements. The rule removes outdated requirements and accommodates new approaches, such as a risk-based inspection frequency for drug establishments. The action is part of the Trump Administration’s initiative
Drugs
The Justice Department has issued a memorandum outlining factors that department attorneys should consider when determining whether to seek dismissal of a whistleblower (qui tam) suit under the False Claims Act. The document notes there have been record increases in the number of whistleblower suits over the last few years.
Drugs
FDA has issued Braeburn Pharmaceuticals a complete response letter on an NDA for CAM2038, an investigational buprenorphine weekly and monthly depot injection for treating adults with opioid use disorder (OUD). In the letter, the agency requested additional information before approval could be considered. The company says the agency did not
Drugs
FDA has published a draft guidance, Hypertension: Developing Fixed-Dose Combination Drugs for Treatment, to assist drug sponsors in clinical development of fixed-dose combination drugs for treating hypertension. The guidance focuses on development of two-drug combinations of previously approved drugs, although FDA says the general approach is readily
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” Comments can now be submitted until 3/30. To view the notice, click here.
Drugs
FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. The drug was previously approved for treating adults with chronic idiopathic constipation (CIC). Approval was based on data from the company’s
Devices
FDA says a finalized guidance issued 12/5/17 modified the agency’s categorization of IDE devices used in clinical investigations. A 1/16 Webinar reviewed the guidance and the rationale for the changes. FDAer Ken Skodacek, who works in the CDRH Clinical Trials Program and in the Payer Communication
Drugs
Endo says it is agreeing to an FDA request that it seek a temporary stay of its 10/2017 suit against FDA seeking a declaration that the agency’s interim policy on compounding using bulk drug substances under Section 503B of the 2013 Drug Quality and Security Act (DQSA) is