PHARMA LITERATI

  The United States Food and Drug Administration (FDA) has approved Lupin's cinacalcet tablets, 30 mg, 60 mg, and 90 mg. Lupin’s cinacalcet tablets, 30 mg, 60 mg, and 90 mg, is the generic version of Sensipar tablets, 30 mg, 60 mg, and 90 mg, of Amgen Inc. It is indicated in the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. Cinacalcet tablets, 30 mg, 60 mg, and 90 mg, had annual sales of approximately US$ 1527 million in the US (IQVIA MAT March 2019). http://www.pharmabiz.com/NewsDetails.aspx?aid=116716&sid=2

Medical device and drug recalls, whether voluntary or forced by the FDA, ensure patient safety. Here is a breakdown of six recalls reported by  Becker's Hospital Review  or published by the FDA in the last two weeks. 1.  Recalled drugs :  Levothyroxine and Liothyronine Reason for recall : Risk of adulteration. The drugs were manufactured using ingredients from a Chinese drugmaker that had deficiencies in its manufacturing practices Date of recall : Aug. 9 Drugmaker : Westminster Pharmaceuticals 2.  Recalled drug :  Valsartan tablets Reason for recall : Detection of probable human carcinogen, n-nitrosodimethylamine Date of recall : Aug. 8 Drugmaker : Camber Pharmaceuticals 3.  Recalled drug :   CVS Health 12-Hour Sinus Relief nasal mist Reason for recall : Product contaminated with bacteria, identified as  Pseudomonas aeruginosa Date of recall : Aug. 8 Drugmaker : Product Quest Manufacturing 4. ...

USFDA recently approved Alecitinib, an antineoplastic agent.  Drug name: Alectinib Innovator: Hoffman-LA Roche Brand name: Alecensa Chemical structure: 9-ethyl-6, 6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5 H-benzo[b]carbazole-3-carbonitrile hydrochloride Indications: Alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK) positive, metastatic non small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Dosage form: Capsule; oral  Strengths: 150mg