FDA's approval of Indian generic drugs surges over last year | Anti-constipation tablet from Valeant, Progenics wins FDA nod | FDA grants breakthrough status to AveXis' spinal muscular atrophy treatment
Eighty-three generic drugs from Indian drugmakers were approved by the FDA during the second half of 2015 and 72 approvals were recorded for the first half of this year, the highest number since 2005. The latest approvals were granted to Sun Pharmaceutical Industries, Glenmark Pharmaceuticals and Aurobindo Pharma for their own generic versions of the cholesterol drug Crestor, or rosuvastatin calcium tablet.
Valeant and Progenics Pharmaceuticals' Relistor tablets, or methylnaltrexone bromide, have been approved by the FDA for the treatment of opioid-induced constipation in adults with chronic noncancer pain. The decision was based on a late-stage trial demonstrating the drug's ability to significantly improve rescue-free bowel movement within four hours of administration over four weeks.
AveXis has received breakthrough therapy status from the FDA for its lead experimental drug candidate, AVXS-101, which is designed to treat children with spinal muscular atrophy type 1. The designation was backed by data from clinical studies conducted in partnership with Ohio State University and the Research Institute at Nationwide Children's Hospital.
ANI Pharmaceuticals' abbreviated new drug application for nilutamide tablets has been approved by the FDA. The drug is indicated as a treatment for metastatic prostate cancer in patients who undergo surgical castration.
The FDA sent a warning letter on June 30 to GlaxoSmithKline's Worthing, England-based facility over serious quality-control problems at the plant, particularly about its failure to prevent cross-contamination of penicillin and nonpenicillin drugs, which was documented a number of times since 2012. The firm has voluntarily recalled batches of its Bactroban antibiotic as a response to the agency's complaint and intends to address the letter by Monday.
The European Medicines Agency granted approval to Gilead's combination hepatitis C therapy Epclusa, or sofosbuvir and velpatasvir, based on positive results from a late-stage study. The drug is indicated for the treatment of six types of chronic hepatitis C in adult patients with compensated cirrhosis or without cirrhosis, and combined with ribavirin for those with decompensated cirrhosis.
The European Commission granted orphan-drug designations to Cell Medica's CMD-003, or baltaleucel-T, for the treatment of post-transplant lymphoproliferative disorder and extranodal NK/T-cell lymphoma, nasal type. The drug is made up of patient-derived immune cells that are activated to kill malignant cells releasing toxins caused by the oncogenic Epstein-Barr virus.
Over 370,000 pounds of corn dogs and hot dogs from Bar-S Foods are being recalled because the chicken and pork used in the products might be contaminated with listeria. The affected products are Bar-S Classic Bun Length Franks, Classic Franks and Classic Corn Dogs, as well as Signature Foods Corn Dogs, all of which were produced between July 10 and July 13.
The FDA has given Medtronic 510(k) clearance for its CD Horizon fenestrated spinal pedicle screw set, which is indicated for treating patients with advanced-stage tumors of the thoracic and lumbar spine. The set is intended for use with the company's HV-R polymethylmethacrylate fenestrated screw cement at spinal levels in which the integrity of the spinal structure is not severely compromised.
The Indian government has included coronary stents of all types on the national list of essential medicines 2015, putting the devices under price control as recommended by a subcommittee report. "Singular focus on capping prices of stents by way of their inclusion in [the] NLEM will not help improve access to medical devices for patients, as it will not impact the overall procedure cost and limit the introduction of innovative products," AdvaMed said.
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