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Novartis

Maker Halts Distribution of Generic Zantac Due to Possible Carcinogen

Preliminary tests revealed low levels of the nitrosamine impurity NDMA in some ranitidine products
A warning letter has been sent to Juul Labs Inc. about illegal claims that its electronic cigarettes are safer than tobacco cigarettes

FDA Warns Juul About Illegal Marketing Claims, Pitch to Youth

FDA questions claims such as Juul is 'much safer than cigarettes' and the 'FDA would approve it any day'
The U.S. Food and Drug Administration has received reports of rare cases of worsening liver function or liver failure in patients with chronic hepatitis C virus who had moderate-to-severe liver impairment and were treated with Mavyret

FDA Reports Rare Cases of Liver Injury, Failure With Hep C Therapies

Worsening liver functioning, liver failure reported among patients contraindicated for HCV therapies
Miracle Mineral Solution

‘Miracle Mineral Solution’ Is No Miracle Cure, FDA Warns

When mixed, the solution develops into a dangerous bleach
The maker of Zolgensma (onasemnogene abeparvovec-xioi) gave manipulated data to the U.S. Food and Drug Administration when it approved the drug

FDA: Approval of Zolgensma Was Based on Manipulated Data

Despite inaccurate data, FDA says it is 'confident that Zolgensma should remain on the market'
New warnings about an increased risk of thrombosis and of death among ulcerative colitis patients taking the 10 mg twice daily dose of the drug tofacitinib (Xeljanz

FDA: Blood Clot, Death Risk Up With Higher Dose of Tofacitinib

Increased risk seen with 10 mg dose of tofacitinib used for treating ulcerative colitis
The U.S. Food and Drug Administration has approved the first noninjection glucagon therapy for emergency treatment of severe hypoglycemia

FDA Approves First Noninjection Glucagon Therapy

Baqsimi nasal powder approved for emergency treatment of severe hypoglycemia in patients ≥4 years
Allergan's textured breast implants will be recalled due to their link to a rare cancer

Allergan Recalls Textured Breast Implants Linked to Lymphoma

FDA requested recall to protect women from breast implant-associated anaplastic large cell lymphoma
Nine drug companies have received approval for the first generic versions of Lyrica (pregabalin)

FDA Grants First Approvals for Generic Versions of Lyrica

Generic versions approved for neuropathic pain management, fibromyalgia, partial onset seizures
The antibacterial drug product Recarbrio (imipenem

Recarbrio OK’d for Complicated Urinary Tract, Intra-Abdominal Infections

Drug approved to treat patients with limited or no alternative antibacterial drugs to treat infection