Drugs
FDA has approved an Allergan supplemental BLA for Botox in treating pediatric patients (two to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs,
Drugs
An FDA safety alert warns that CholesLo, a product promoted and sold for lowering cholesterol on various Web sites, including www.choleslo.com, contains an undeclared ingredient. An agency laboratory analysis confirmed that CholesLo contains undeclared lovastatin, which is the active ingredient in Merck’s Mevacor and generic equivalents, the
Drugs
FDA has issued a draft guidance, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, with information on the provision in the law authorizing FDA to require certain postmarketing studies and clinical trials for certain prescription drugs and biological products.
Drugs
Federal Register notice: FDA has submitted to OMB an information collection extension for “Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). The Food, Drug, and Cosmetic Act authorizes the agency to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets
Drugs
Harvard Medical School researchers say that although the level of biosimilar testing needed for FDA approval exceeded the European Medicines Agency (EMA) level soon after the FDA biosimilar pathway was established, that is no longer the case. The researchers looked at 16 biosimilars of nine originator biologics that had been
Drugs
FDA has announced a 12/5 public meeting on its Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program. The meeting is intended to allow grantees to share their development plans for the standard core COA sets and to receive feedback from stakeholders. FDA will also provide an
Drugs
FDA has granted Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia. The company announced an open IND for mRNA-3927 on 9/30. Moderna says it is preparing to initiate a Phase 1/2 clinical study to evaluate the therapy’s potential to
Drugs
Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohn’s disease drug PRV-6527, an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor, showed that the therapy did not perform better that placebo. The study enrolled 93 moderate-to-severe Crohn’s disease
Drugs
FDA has released the FDA-483 issued following a 6/19-6/23 inspection at East Marietta Drug Company, Marietta, GA, a producer of non-sterile drug products. The three inspection observations on the form were: * production of highly potent drugs without providing adequate cleaning of work surfaces to prevent
Drugs
FDA has denied all requests in a Public Citizen 6/29/16 petition involving dopamine agonists and most requests in a BioMedEcon 6/2/17 petition involving certain specific dopamine agonists. Public Citizen had asked that FDA (1) add a Boxed Warning to labeling for all dopamine agonists describing the
Drugs
FDA has made available a final guidance entitled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers.” The document is intended to clarify agency expectations on facility information that should be included in original NDAs, ANDAs, BLAs, and chemistry, manufacturing, and controls supplements. It discusses
Drugs
A 4/1-4/5 FDA inspection at Jiangsu NHWA Pharmaceutical Co., Jiangsu Sheng, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A just-released 9/10 Warning Letter says specific deviations were: * failing to ensure that all sampling plans and test procedures
Drugs
FDA has accepted for review an IntelGenx 505(b)(2) NDA resubmission for Rizaport VersaFilm (rizatriptan ) an oral disintegrating film for treating acute migraine. Rizatriptan is the active ingredient in Merck’s migraine drug Maxalt-MLT. IntelGenx says the selective 5-HT1B/1D receptor agonist demonstrates the highest efficacy and
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Jiangsu NHWA Pharmaceutical Co., Jiangsu, China (9/10): FDA inspected the firm in April and cited significant GMP deviations for active pharmaceutical ingredients (APIs). For example, the company failed
Drugs
The Gastroparesis Clinical Research Consortium says it agrees with many statements in a recent FDA guidance on gastroparesis that “provides much needed information for conducting clinical trials for pharmaceutical companies for drug approval for gastroparesis.” The consortium’s comment letter raises concerns in these areas: * FDA is sending a conflicting
Drugs
FDA has approved a Vertex Pharmaceuticals NDA for Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy to treat patients with the most common cystic fibrosis mutation. Trikafta gained approval for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis
Drugs
FDA has approved AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure in adults with Type-2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Approval is based on data from the DECLARE-TIMI 58 cardiovascular outcomes trial. The first-in-class, oral once-
Drugs
FDA has made available a draft guidance entitled “Drug Master Files.” The document provides current thinking on the submissions that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types
Drugs
Several lawmakers have written a letter to FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recall of its hypoparathyroidism drug Natpara (parathyroid hormone). The letter notes that more than 2,000 need the drug to manage their blood calcium levels. It says several patients who
Drugs
Bayer has submitted a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg. The submission seeks to extend the indication to up to six years of pregnancy prevention based on results from a Phase 3 extension trial evaluating Mirena’s
Drugs
FDA has released a Form-483 from a July inspection at Ram Pharma’s Idaho Falls, ID outsourcing facility. According to the inspection observations, aseptic processing areas were found deficient, particularly the system for monitoring environmental conditions. The agency also cited the firm’s system for cleaning and disinfecting the
Drugs
BIOLOGICS CSL Behring has received FDA approval of Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for treating hemophilia B. The company says Idelivion is the first factor IX therapy that delivers high-level protection