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Tag Archives: FDA

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FDA Approves Greenfield Company’s Canine Itch Medicine

InkFreeNews.com Posted Sep 24, 2024  Updated: Sep 24, 2024 @ 2:50 PM

Elanco Animal Health Incorporated announced the U.S. Food and Drug Administration has approved Zenreli, a highly effective and convenient once-daily oral JAK inhibitor for control of itching associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

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Posted in Breaking News, Scheduled Post | Tagged canine, dermatitis, dog, elanco, FDA, itch, medicine, U.S. Food and Drug Administration, Zenrelia | | Buy Photos | Contact Author

FDA Approves Alzheimer’s Medication

InkFreeNews.com Posted Jul 05, 2024  Updated: Jul 4, 2024 @ 7:36 AM

The U.S. Food and Drug Administration has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease.

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Posted in Breaking News | Tagged Alzheimer's, drugs, FDA, medical, medicine, pharmaceuticals | | Buy Photos | Contact Author

Indiana Animal Health Board Offers Update On Dairy Cow Illness

InkFreeNews.com Posted Mar 26, 2024  Updated: Mar 26, 2024 @ 9:10 AM

An illness spreading among dairy cows in some states has not yet been detected in Indiana, according to state officials, but producers should be on the lookout.

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Posted in Archive 2024 | Tagged CDC, Centers for Disease Control and Prevention, dairy cows, FDA, Food and Drug Administration, highly pathogenic avian influenza, HPAI, Indiana State Board of Animal Health, U.S. Department of Agriculture, USDA | | Buy Photos | Contact Author

Warsaw’s OrthoPediatrics Receives FDA Clearance For New Surgical System

InkFreeNews.com Posted Sep 15, 2023  Updated: Sep 15, 2023 @ 8:26 AM

OrthoPediatrics Corp., a company focused exclusively on advancing the field of pediatric orthopedics, announced Monday, Sept. 11, it has received 510(k) clearance from the U.S. Food and Drug Administration for its Pediatric Nailing Platform | Tibia (“PNP Tibia”) surgical system.

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Posted in Archive 2023 | Tagged FDA, Joe Hauser, orthopediatrics corp, Pediatric Nailing Platform, PNP Tibia System, Trauma & Deformity Correction business | | Buy Photos | Contact Author

Zimmer Biomet Receives ‘Concerns’ From FDA

InkFreeNews.com Posted Feb 03, 2017  Updated: Feb 3, 2017 @ 3:33 PM

WARSAW — Zimmer Biomet has recently received a Form 483 notice from the FDA. The Form 483 is used by the FDA to document and communicate concerns discovered during routine inspections at the north campus location in Warsaw. The notice was sent to David Kunz, Senior Vice President after … Read More

Posted in Archive 2017, Business | Tagged 483, FDA, Zimmer Biomet | | Buy Photos | Contact Author

Federal Authorities Warn Against Fake, Decorative Contact Lenses

InkFreeNews.com Posted Oct 25, 2016  Updated: Oct 25, 2016 @ 8:46 AM

WASHINGTON  — Federal law-enforcement authorities are reminding consumers to avoid dangerous and unapproved decorative contact lenses this Halloween. According to officials, these illegal contact lenses sold at retail outlets and online can cause eye infections, conjunctivitis and impaired vision. U.S. Immigration and Customs Enforcement (ICE), U.S. Food and … Read More

Posted in Around Us | Tagged Costumes, Fake Contacts, FDA, Halloween | | Buy Photos | Contact Author

New Concern About Safety Of Raw Cookie Dough Arises

InkFreeNews.com Posted Jul 01, 2016  Updated: Jul 1, 2016 @ 10:23 AM

SOUTH BEND — A lot of people know about the danger of salmonella poisoning from uncooked eggs in raw dough.

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Posted in Around Us | Tagged Cookie Dough, FDA, Raw Cookie Dough, salmonella | | Buy Photos | Contact Author
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FDA Defends Response To Medtronic Reporting Delay

InkFreeNews.com Posted Jun 24, 2016  Updated: Jun 24, 2016 @ 8:24 AM

WARSAW — The U.S. FDA is defending its response to a delay in reporting by MedTronic of injuries allegedly caused by its Infuse bone growth product. MassDevice cites a recent article by the Minneapolis StarTribune, which took an in-depth look at the situation and reported on MedTronic’s delay … Read More

Posted in Archive 2016, Business | Tagged business, FDA, Medtronic | | Buy Photos | Contact Author

Warning Issued To Zimmer Montreal Plant

InkFreeNews.com Posted Jun 06, 2016  Updated: Jun 6, 2016 @ 3:05 PM

WARSAW — The Food and Drug Administration has issued a warning to the Montreal, Quebec, Canada, plant of Zimmer-Biomet Inc. pertaining to requirement nonconformities. The Food and Drug Administration performed an inspection of the facility, ORTHOsoft Inc., earlier in May and completed the required Form 483 listing observations made … Read More

Posted in Archive 2016, Business | Tagged FDA, Food and Drug Adminisration, Violations, Zimmer Biomet, Zimmer Biomet Inc.'s Montreal Quebec Canada facility | | Buy Photos | Contact Author

Hostess Recalls Thousands Of Snack Cakes, Donuts

InkFreeNews.com Posted Jun 06, 2016  Updated: Jun 6, 2016 @ 11:50 AM

NEW YORK — Hostess Brands is recalling snack cakes and donuts because they may have come in contact with peanut residue.

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Posted in Around Us | Tagged Ding Dongs, donuts, FDA, Food recall, Hostess | | Buy Photos | Contact Author

Zimmer Biomet Announces FDA Clearance

InkFreeNews.com Posted Feb 11, 2016  Updated: Feb 11, 2016 @ 4:39 PM

WARSAW — Zimmer Biomet Holdings, a global leader in musculoskeletal healthcare, announced it has received 510(k) clearance from the US Food and Drug Administration for the Unite3D Bridge Fixation System, a 3D-printed technology designed to offer stability in foot and ankle arthrodesis surgery. Featuring Zimmer Biomet’s proprietary OsseoTi porous … Read More

Posted in Business | Tagged FDA, Unite3D Bridge Fixation System, Zimmer Biomet, Zimmer Biomet Holdings | | Buy Photos | Contact Author

Nextremity Solutions Receives FDA Approval For Bunion Correction System

InkFreeNews.com Posted Dec 23, 2015  Updated: Dec 23, 2015 @ 3:11 PM

WARSAW — Nextremity Solutions Inc., a surgeon-driven, pure-play foot and ankle orthopedic company located in Warsaw, announced it has received 510(k) approval by the Food & Drug Administration to market its upcoming Axi+Line Proximal Bunion Correction System. “The Axi+Line Proximal Bunion Correction System represents a significant advancement in the … Read More

Posted in Business | Tagged 510(k) approval, FDA, Food and Drug Administration, Nextremity Solutions Inc. | | Buy Photos | Contact Author
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Zimmer Biomet Announces GEL-One FDA Approved

InkFreeNews.com Posted Dec 02, 2015  Updated: Dec 2, 2015 @ 9:19 AM

WARSAW — Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, is pleased to announce an expanded safety claim from the U.S. Food and Drug Administration for Gel-One® Cross-linked Hyaluronate, indicating that this single-injection viscosupplement for the knee joint is safe for use in repeat treatments.   … Read More

Posted in Business | Tagged FDA, Gel-One Hyaluronate, Zimmer, Zimmer Biomet | | Buy Photos | Contact Author
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Lilly Diabetes Treatment Performs Well In Study

InkFreeNews.com Posted Aug 20, 2015  Updated: Aug 20, 2015 @ 3:49 PM

By ANDY OBER InsideINdianaBusiness INDIANAPOLIS — Indianapolis-based Eli Lilly and Co. says the diabetes treatment Jardiance met its primary endpoint in a latest clinical trial. The company says the treatment lowered cardiovascular risk in adults with type 2 diabetes. Lilly says the long-term trial involved more than 7,000 … Read More

Posted in Business | Tagged Diabetes, FDA, Jardiance, Lilly | | Buy Photos | Contact Author
Kraft cheese recall

Kraft Recalling Cheese Singles For Choking Hazard

InkFreeNews.com Posted Aug 03, 2015  Updated: Aug 3, 2015 @ 12:16 PM

MINNESOTA — The Kraft Heinz Company has announced a voluntary recall of select varieties of Kraft Singles due to a potential choking hazard. The recall applies to three pound and four pound sizes of Kraft Singles American and White American pasteurized prepared cheese product. The company has said … Read More

Posted in Around Us | Tagged FDA, full refund, Kraft Heinz Company, Kraft Singles, packaging film, potential choking hazard, return to store, voluntary recall | | Buy Photos | Contact Author

Kroger Recalling Spices Due To Possible Salmonella Contamination

InkFreeNews.com Posted Jul 28, 2015  Updated: Jul 28, 2015 @ 9:29 AM

INDIANAPOLIS — Kroger announced a recall Monday, July 27, of its store brand ground cinnamon, garlic powder, coarse ground black pepper and Bac’n Buds products because of possible salmonella contamination. The Food and Drug Administration tested a sample of garlic powder from a store in North Augusta, South … Read More

Posted in Around Us | Tagged Bac'n Buds, coarse ground black pepper, FDA, garlic powder, ground cinnamon, Kroger, recall, return for refund, salmonella | | Buy Photos | Contact Author

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