USFDA

U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud. The FDA is warning consumers to be alert, and try and steer clear of fraudulent flu products, which may be found online or in retail stores. The agency protecting consumers of unapproved products claiming to prevent, treat or cure influenza, or flu.

In its continued efforts to protect consumers and ensure food safety, the U.S. Food and Drug Administration has begun testing fresh cilantro, parsley and basil, as well as processed avocado and guacamole, for certain microbial contaminants. These two large-scale sampling assignments will help the FDA assess the rates of bacterial contamination in these commodities, as well as help to identify possible common factors among the positive samples.

FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later.

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The U.S. Food and Drug Administration announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom.

FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced  that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor, for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved treatment for these patients. Today’s approval follows an FDA Priority Review designation based upon data from the Phase 3 SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC.

Jubilant Life Sciences Ltd has received Abbreviated New Drug Application (ANDA) final approval for Amantadine Hydrochloride Tablets, 100 mg, the generic version of Symmetrel® of Endo, which is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions.

Dr. Reddy’s Laboratories Ltd announced that it has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine® (tetrabenazine) in the United States market approved by the U.S. Food and Drug Administration (USFDA).

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings from the U.S. Food and Drug Administration’s (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO® (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety. Building on the mounting real-world evidence studied in more than 200,000 people, these findings are consistent with conclusions from other analyses and again confirm XARELTO®’s safety and effectiveness across a wide range of patients. The FDA Mini-Sentinel report also notes a lower risk of ischemic stroke was associated with the use of XARELTO® compared to warfarin and lasted throughout the more than three-year analysis.