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Save-The-Date
SPA 2019 Pharma Conference
April 3-5, 2019
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Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
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Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.
The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall. Patients who are on these products should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
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FDA approves new treatment for adult patients with rare, life-threatening blood disease
The U.S. Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. PNH is a rare acquired disorder that leads to the rupture or destruction of red blood cells (hemolysis). Ultomiris is a long-acting complement inhibitor that prevents hemolysis. Prior to this approval, the only approved therapy for PNH required treatment every two weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every eight weeks, without compromising efficacy. Read more
here.
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Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
2,000 Human Brains Yield Clues to How Genes Raise Risk for Mental Illnesses PsychENCODE researchers are discovering the biological mechanisms by which mental illness risk genes work in the human brain. Fifteen collaborating research teams of the National Institutes of Health- (NIH-) funded PsychENCODE Consortium leveraged statistical power gained from a large sample of about 2000 postmortem human brains. Applying newly uncovered secrets of the brain's molecular architecture, they developed an artificial intelligence model that's six times better than previous ones at predicting risk for mental disorders. Read more with Control/Click on the colored title at the beginning of this paragraph.
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'Exercise Hormone' Tied to Bone-Strengthening Benefits There's no doubt that exercise is good for us-strengthening our muscles, helping us maintain a healthy weight, maybe even boosting our moods and memories. There's also been intriguing evidence that exercise may help build strong bones. Now, an NIH-funded study is shedding light on the mechanism behind exercise's bone-strengthening benefits... Control Click on
Read More...
Centers for Disease Control and Prevention has revised Physical Activities for Americans. Be sure to Check out the new
New Physical Activity Guidelines for Older Adults (Chapter 5). Control/Click on the colored title above to read the guidelines.
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Guidance for Industry (click or control/click on the colored title to download)
2.)
Guidance for Industry: Data Integrity and Compliance with Drug CGMP Questions and Answers.
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Guidance for Industry: Current Good Manufacturing Practice - Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. Download copy here.
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FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (active ingredient alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. We have also added the risk of stroke to the existing Boxed Warning, FDA's most prominent warning.
Listen
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Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product (00717009A, 0071015A, & 00717924A) have been found to potentially have higher concentrations of ibuprofen. They were sold at Walmart, CVS Pharmacy and Family Dollar Stores. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.
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Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC). These batches were distributed in the U.S. between March 2017 and November 2018.
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Warning Letters
Skylark CMC Pvt. Ltd., Ahmedabad, Gujarat 382415 INDIA
On June 25, 2018, the U.S. Food and Drug Administration (FDA) arrived at your drug manufacturing facility, Skylark CMC Pvt. Ltd. near Electric Sub Station, Odhav Road, Ahmedabad, Gujarat, to conduct an inspection. Our investigator documented that your firm limited and/or refused an FDA inspection. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration and Innovation Act (FDASIA), section 707, 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.
CAO Medical Equipment Co. Ltd., Langfang, Hebei, 065001 CHINA
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
1. Your firm failed to perform appropriate laboratory determination of satisfactory conformance to final specifications for purity, strength, and quality
2. Your firm failed to validate and establish the reliability of your suppliers test analysis at appropriate intervals.
3. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance
4. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess
Zhejiang Huahai Pharmaceutical Co. Ltd., Taizhou, Zhejiang, 317016 CHINA
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility.
1. Failure of your quality unit to ensure that quality-related complaints are investigated and resolved.
2. Failure to evaluate the potential effect that changes in the manufacturing process may have on the quality of your API.
Corona Doctors Medical Clinics, Inc., Corona, California 92879
This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site
1. As the authorized representative of the sponsor Corona Doctors Medical Clinics, Inc., you violated a clinical hold by giving subjects an investigational drug after FDA issued an order to delay a proposed clinical investigation.
2. You administered an investigational new drug to human subjects without an effective Investigational New Drug application (IND).
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Products Containing Hidden Drug Ingredients: MOB Candy and Willy Go Wild contain sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
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