Drugs
An FDA briefing paper released in advance of the 11/14 Endocrinologic and Metabolic Diseases Advisory Committee discussion of Amarin’s Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. MSM Nutraceuticals, Phoenix, AZ (10/24): FDA inspected the firm in May and cited significant GMP violations for finished pharmaceuticals. For example, MSM failed to perform, for each batch
Drugs
FDA principal deputy commissioner for policy Lloyd Schiller told the Council for Responsible Nutrition 11/7 that FDA is looking at possible changes to law that would enable the agency to keep pace with changes in the dietary supplement market that has grown significantly in the last 25 years under
Drugs
FDA has placed on clinical hold the Solid Biosciences IGNITE DMD Phase 1/2 study of the company’s SGT-001 under investigation to treat Duchenne muscular dystrophy. The company says that to date six patients have been dosed with SGT-001. It reports that the third patient experienced a
Drugs
FDA has granted F2G Ltd. a breakthrough therapy designation for olorofim for treating invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species. The company says that olorofim is the
Drugs
FDA has issued Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for hormone replacement therapy in adult males for conditions associated with hypogonadism. The letter said Lipocine’s drug efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations (Cmax)
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Format and Content Requirements for Over-the-Counter Drug Product Labeling — 21 CFR Part 201” (OMB Control Number 0910-0340). The collection supports FDA regulations that establish standardized content and format requirements for OTC drug product labeling,
Drugs
Start-up pharmacy Valisure (New Haven, CT) has made a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling prescriptions for consumers. The pharmacy's laboratory analysis is behind the ongoing recall of ranitidine, (see earlier story) and it has detected dozens of other quality
Drugs
Regenxbio has filed a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases. The complaint alleges that FDA’s final agency action is “contrary to law and arbitrary and capricious because it did not follow the statute or its own regulations,
Devices
FDA has granted AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy images for potential diagnosis of gastric cancer. The company says its system “applies neural network algorithms which are trained with large real-world datasets of images of biopsy-proven cancer lesions, benign
Drugs
FDA has granted Allergan a Qualified Infectious Disease Product designation and fast track status for ATM-AVI (aztreonam and avibactam) for treating complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. ATM-AVI has shown activity against metallo beta-lactamase-producing Gram-
Drugs
FDA Withdraws Haemonetics ANDA Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags. 11/08/2019 Info Collection on Generic Drug Correspondence Federal Register notice: FDA submits to OMB an information collection revision entitled for “Controlled Correspondence Related to Generic
FDA Policy/General
AMPAC Fine Chemicals has acquired UniTao Pharmaceuticals’ active pharmaceutical ingredient manufacturing facility in Petersburg, VA. The facility includes four plants with multiple cGMP manufacturing lines totaling more than 80,000 gallons of cGMP capacity. It has a long history of producing Schedule II controlled substances, and its capabilities include high
Drugs
Aurobindo is recalling 38 lots of over-the-counter ranitidine tablets (150 mg), Rx ranitidine capsules (150 mg and 300 mg), and ranitidine syrup (15mg/mL). An FDA notice says the medications contain unacceptable levels of N-nitrosodimethylamine (NDMA). The notice says FDA has advised companies to recall their ranitidine
Drugs
FDA has approved Celgene’s Reblozyl (luspatercept-aamt), the first therapy to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. An agency notice says that beta thalassemia (Cooley’s anemia) is an inherited blood disorder that reduces the production of hemoglobin. In people
Drugs
FDA has accepted for review a Cassiopea NDA for clascoterone cream 1% for treating acne. The agency has set a user fee review action target of 8/27. Clascoterone is a new chemical entity and first-in-class topical androgen receptor inhibitor, which is also under development for treating under
FDA Policy/General
President Donald Trump told reporters at the White House 11/8 that the administration’s new rules on e-cigarettes should be out within a week. An element in the plan will involve raising from 18 to 21 the legal age for purchasing vaping products, he said. The Hill reports
Devices
Teleflex has begun a Class 1 recall of its Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is used with its ventilators, because the device’s vented gas is below the stated pressure. A company communication to customers instructs them to quarantine affected products, according to a recall
Devices
A New York federal judge has approved a settlement between the Justice Department and Life Spine Inc., and two of its executives, resolving a whistleblower’s allegations that they paid millions of dollars in kickbacks to surgeons to induce them to use the company’s spinal implants, devices, and equipment.
Devices
CDRH Office of Product Evaluation and Quality regulatory advisor Joshua Silverstein says FDA revised a 9/28/18 draft guidance on a proposed new Special 510(k) policy in response to comments received on it. Speaking during a CDRH Webinar on the finalized guidance that was issued 9/13, Silverstein
Drugs
AbbVie has submitted a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of patients 70 years old or younger with chronic lymphocytic leukemia or small lymphocytic lymphoma. The submission is based on data from the Phase 3 E1912 study, which was sponsored by the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags because the company notified the agency that the drug is no longer being marketed. To view the notice, click here.