Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA’s efforts to identify alternative or streamlined mechanisms for complying with GMPs for combination products. In comments to an agency notice on the efforts, PhRMA sought additional clarity on certain elements of the mechanisms outlined in the notice, and
Drugs
FDA is hosting a 10/15-16 public workshop to convene a discussion on: 1) methodological approaches that may be used to develop and identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in managing a
Drugs
House Republicans last week derailed a Trump-supported amendment to a health care spending bill that would have required drug companies to include prices in their direct-to- consumer advertising. Last month, the Senate passed the bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL)
Drugs
FDA has approved a Sun Pharmaceutical Industries NDA for Xelpros (latanoprost ophthalmic emulsion) 0.005% for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company says Xelpros is the only form of latanoprost that is not formulated with benzalkonium chloride, a preservative commonly used
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) has filed a lawsuit against FDA in eastern PA federal court seeking an order to compel the agency to provide a hearing on its decision not to approve the company’s NDA for oxycodone hydrochloride immediate-release oral capsules (see earlier story). In the complaint,
Drugs
FDA has approved AstraZeneca Pharmaceuticals’ Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for treating adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the
Drugs
Pharm D Solutions has recalled all sterile compounded drug products within expiry due to concerns that practices at the pharmacy have the potential to pose a contamination risk to products that are intended to be sterile. The decision to recall the products followed a routine inspection of the pharmacy by
Drugs
FDA has approved a Staar Surgical PMA supplement for the Visian Toric Implantable Collamer Lens (ICL) for the correction of myopia with astigmatism. The ICL will be available in both spherical and toric designs. The device is indicated for use in patients 21-45 years of age to correct myopic
Drugs
FDA says its latest testing of products with the active pharmaceutical ingredient (API) valsartan shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled products. An agency news release says that the second impurity, N-Nitrosodiethylamine (NDEA), is a known animal and suspected human carcinogen. The release also
Drugs
FDA has released the FDA-483 issued following an 11/13-11/17/17 inspection at Yuki Gosei Kogyo, a Fukushima, Japan, active pharmaceutical ingredient (API) manufacturer. The document contains nine specific inspection observations: * laboratory control procedures are not followed; * records associated with drug substance production and within the retention
Drugs
A FDA-483 issued following a 4/23-4/27 and 4/30-5/1 inspection at Cook Pharmica, Bloomington, IN, has five inspection observations. They are: * there is an unacceptably high number of mold recoveries in the classified rooms for manufacture of a redacted bulk drug substance; * written procedures
Drugs
FDA has released the FDA-483 issued following a 7/23-7/27 inspection at Unichem Laboratories, Pithampur, Dhar, India. Specific observations at the drug manufacturing firm were: * cleaning procedures are not validated; * test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labels
Drugs
FDA has released additional draft and revised draft product-specific drug guidances. A Federal Register notice to be published 9/14 says the guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs. Comments on the drafts will be accepted for 60 days.
Drugs
FDA has released an FDA-483 issued following an 8/27-8/31 inspection at the Sun Pharmaceutical Industries drug manufacturing facility in Halol, Gujarat, India. Specific observations listed in the document were: * laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that
Drugs
FDA has released the FDA-483 issued following an 8/20-8/28 inspection at Liva Pharmaceuticals, Gujarat, India. The document lists these inspection observations: * procedures designed to prevent microbiological contamination of sterile small volume parenteral drug products purporting to be sterile are not followed; * aseptic processing areas are deficient
Drugs
FDA has accepted for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing Information to include its effect in reducing the overall risk of major adverse cardiovascular events (MACE). MACE is a catch-all term that includes heart attack, ischemic stroke, death from coronary
Drugs
FDA has granted Syntimmune an orphan drug designation for SYNT001 for treating pemphigus. The designation is based on positive preliminary results from a Phase 1b proof-of-concept trial in pemphigus patients, a rare and severe autoimmune disease that leads to painful blistering. Data showed that SYNT001 appeared to be
Drugs
FDA has issued a guidance, Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications, with recommended technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data from ANDAs should be submitted using FDA-supported data
Drugs
A Tufts Center for the Study of Drug Development analysis of 509 drugs and biologics approved by FDA from 2000 to 2017 found that central nervous system (CNS) drugs take 20% longer to develop and approve versus non-CNS products. “Due to the complex nature of the conditions they are
Drugs
A 12/4-12/12/17 FDA inspection at Lernapharm (Loris), Montreal, Canada, found significant violations of current good manufacturing regulations for finished pharmaceuticals, according to a 9/4 Warning Letter to the company. Specific violations cited in the letter were: * failing to establish and follow appropriate written procedures that
Drugs
The Biotechnology Innovation Organization (BIO) applauds an FDA draft guidance with recommendations on general principles to consider when drafting an indication and how to write, organize, and format the information in the Indications and Use section of labeling. The BIO letter particularly commends the agency for recognizing that an indication
Drugs
An FDA 8/27-8/31 inspection at the Lupin Tarapur, India, drug manufacturing facility closed with one inspection observation that the company termed a “procedural deficiency” in a statement to news media in India. The statement says the inspection focused on cGMP compliance and also on the safety of