USFDA

U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

Cipla Limited, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, Phenylephrine Hydrochloride Injection USP, 10 mg/mL Single- Dose Vial and Exemestane Tablets, 25mg from the United States Food and Drug Administration (USFDA).

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U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued 13 warning letter to manufacturers, distributors, and retailers for selling e-liquids used in e-cigarettes that resemble kid-friendly food products, such as juice boxes, candy or cookies, some of them with cartoon-like imagery.

The Food and Drug Administration (FDA) has issued warning regarding the use of lamotrigine and the possibility of hemophagocytic lymphohistiocytosis (HLH), a rare but serious immune system reaction. The FDA is requiring that a new warning be added to the prescribing information for all lamotrigine products to alert of this possible side effect.

U.S. Food and Drug Administration authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients.

The U.S. Food and Drug Administration announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). The agency has released guidance intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Topical Solution USP, 0.05%, the generic version of Temovate® Topical Solution, 0.05%, of Fougera Pharmaceuticals, Inc. This product will be manufactured at Glenmark’s Baddi plant in India.

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The U.S. Food and Drug Administration approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life.

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Apricus Biosciences, Inc a biopharmaceutical company advancing innovative medicines in urology and rheumatology,  announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.