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
July 21, 2016
FDLI SmartBrief
News for the food and drug law community
SIGN UP ⋅   FORWARD
Drugs & Biologics
FDA's approval of Indian generic drugs surges over last year
Pharmaceuticals
(Franck Fife/AFP/Getty Images)
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.
Bloomberg (7/20),  The Hindu (India) (7/21) 
Email
 
Anti-constipation tablet from Valeant, Progenics wins FDA nod
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.
Pharmaceutical Business Review Online (7/20) 
Email
FDA grants breakthrough status to AveXis' spinal muscular atrophy treatment
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.
Benzinga.com (7/20) 
Email
ANI Pharmaceuticals' generic nilutamide tablets cleared by FDA
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.
PharmaBiz.com (India) (7/20) 
Email
GSK warned by FDA over contamination at penicillin plant
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.
STAT (7/20) 
Email
How ERP can help simplify manufacturing
Digital technologies are increasingly becoming integrated into the manufacturing landscape, driving the need for simpler ways to access information to support decision making. Read this whitepaper.
ADVERTISEMENT
Global Focus
Gilead's hepatitis C drug approved in EU
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.
PharmaTimes (U.K.) (7/20) 
Email
Cell Medica gains EU orphan designations for cancer drug
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.
European Pharmaceutical Review (U.K.) (7/20) 
Email
Food & Dietary Supplements
Listeria fears prompt recall of Bar-S Foods' corn dogs, hot dogs
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.
CNN (7/20) 
Email
Medical Devices
FDA clears spinal pedicle screw set from Medtronic
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.
MassDevice.com (Boston) (7/20) 
Email
India lists coronary stents as essential medicines
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.
Business Standard (India)/Press Trust of India (7/20),  LiveMint.com (India) (7/21) 
Email
FDLI Items
Introduction to Food Law and Regulation Course, Sept. 22-23, San Francisco, Calif.
FDLI Food Law
Gain a comprehensive understanding of the various administrative agencies that impact the food industry and learn about pending regulations, food safety, food labeling, enforcement and related issues. The sessions are presented by leading experts in the field. This intensive introductory training course covers the essentials of food, dietary supplements and cosmetics law and regulation. View the agenda.
Email
 
Tobacco Conference: Tobacco, Nicotine, and Alternative Products at a Regulatory and Legislative Crossroads, Oct. 27, Washington, D.C.
FDLI deeming regulations
This conference will provide the latest updates and developments in the regulation of tobacco, nicotine and alternative products. Speakers include representatives from the FDA, law, industry, public health and academia. This day provides a unique opportunity for all stakeholders to come together in a neutral, unbiased educational forum. Learn more.
Email
 
Learn more about FDLI:
About FDLI | Join FDLI | Conferences | Publications
JOBS
powered by
Vice President, Technical - Strategic Compliance
PAREXEL - 
Assistant General Counsel, Job ID 1034078
PFIZER INC. - New York, NY
Mid-Level Associate
HYMAN, PHELPS & MCNAMARA, P.C. - DC
Associate - Food and Drug
KELLER AND HECKMAN LLP - Washington, DC
  
  
Do not fear to be eccentric in opinion, for every opinion now accepted was once eccentric.
Bertrand Russell,
philosopher and historian
Email
  
  
Sign Up
SmartBrief offers 200+ newsletters
Advertise
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Advertising  -  Meryl Harold
P: 202.407.7828
Jobs Contact  -  jobhelp@smartbrief.com
Editor  -  Lisa Gough
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2016 SmartBrief, Inc.®
Privacy policy |  Legal Information