April 2019

Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos

March 29

March 27

FDA has approved new oral testosterone capsule (Jatenzo) for treatment of men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo should not be used to treat men with "age-related hypogonadism," in which testosterone levels decline due to aging, even if these men have symptoms that appear to be related to low testosterone. Jatenzo's benefits do not outweigh its risks for that use including its effects on raising blood pressure that increase the risks of heart attack, stroke and cardiovascular death in this population.

FDA Commissioner Scott Gottlieb, M.D. has announced enforcement discretion to accommodate unique circumstances faced by producers of hops, wine grapes, pulse crops and almonds. The Food Safety Modernization Act empowered the FDA to enact a more modern, preventive and risk-based approach to food safety with a focus on setting common-sense safety standards for food producers to protect public health, so after they received feedback on the application of this rule from stakeholders of certain commodities, including hops, wine grapes, pulse crops and almonds, the FDA does not expect producers of these commodities to comply with the Produce Safety Rule.

Warning Letters (the following are representative samples of warning letters issued this month)

Tec Laboratories, Inc. Albany, OR 97321

1. Failure to conduct appropriate laboratory testing, as necessary, of each batch of topical OTC and homeopathic drug product required to be free of objectionable microorganisms.

2. Failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

3. Your firm is marketing an unapproved new drug advertised as "Calagel".

B. Jain Pharmaceuticals Pvt. Ltd., Bhiwadi-301707 Rajasthan, India

1. Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin.

2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

3. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.

4. Your firm is marketing misbranded homeopathic drugs.

King Bio, Inc., Asheville, NC, Inc. 28806

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

2. Your firm failed to establish adequate written procedures for production (e.g. process validation) 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.

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.

Inopak Ltd., Ringwood, NJ 07456

1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

2. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing.

3. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit.

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.

Nutra Pharma Corp. Coral Springs, FL 33071

You are illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.

March 26

Rare Diseases: Natural History Studies for Drug Development - Draft Guidance. Download your copy  here.

March 25

USA LESS is voluntarily recalling all lots of LEOPARD Miracle Honey, to the consumer level. FDA analysis has found LEOPARD Miracle Honey to be tainted with sildenafil.  Sildenafil is an FDA approved drug for the treatment of male erectile dysfunction.  The presence of sildenafil in LEOPARD Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

BLUEFUSION Capsules by Ata Int.: Recall - Due to Presence of Undeclared Sildenafil, Tadalafil, Desmethyl Carbodenafil, Dithiodesmethyl Carbodenafil, Scutellarin and Daidzein.  The presence of the undeclared active ingredients renders the product an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

Kingston Pharma, LLC Recalls DG™/health NATURALS baby Cough Syrup + Mucus" Because of Possible Health Risk. This product has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea.

FDA warns about safety concerns related to investigational use of Venclexta (venetoclax) for multiple myeloma. Today, the FDA posted a safety statement to alert health care professionals and patients about the suspension of a clinical trial of bortezomib and low-dose dexamethasone with or without Venclexta in patients with relapsed and refractory multiple myeloma, due to an increased risk of death for patients receiving Venclexta when it was combined with bortezomib and dexamethasone as compared to the control group. The FDA has required that patients in this clinical trial be discontinued from further treatment, because interim results from the trial demonstrate an increased risk of death for patients receiving Venclexta when it was combined with bortezomib as compared to the control group.

Hill's Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. For a list of affected food click this link.

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements. The warning letters were issued to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. These studies are needed to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

FDA approves first treatment for postpartum depression. The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing.

FDA has approved atezolizumab for extensive-stage small cell lung cancer. FDA approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer.

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter.  The lots (APB032 and APB033) of Levoleucovorin injection. 250 mg/25 mL, were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. The Levoleucovorin Injection is being recalled due to the presence of particulate matter identified as copper salts. The particulate matter was discovered during 12-month stability testing.

FDA allows marketing of new device to help treat carbon monoxide poisoning.  ClearMate-a device consisting of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask and hoses-works by speeding up the elimination of carbon monoxide from the body. It delivers both 100 percent oxygen to the patient, as well as a mixture of oxygen and carbon dioxide, causing the patient to breathe faster. The increased breathing accelerates the rate at which the carbon monoxide leaves the patient's body, allowing a normal amount of oxygen to attach to hemoglobin and be carried where it is needed throughout the body.

FDA takes steps to help reduce risks associated with surgical staplers and implantable staples. The FDA issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples-common devices used in many  surgeries-and to provide updated recommendations to help reduce risks associated with their use. 

McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water. All lots of Life-Line Water are being recalled to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa.   The product was distributed in the United States and Canada to individuals via internet [email protected].

FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic. The FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through certified doctor's office or clinic.

Expired FDA Forms The Agency has been receiving many inquiries from the pharmaceutical industry asking about the validity of expired FDA forms and when new versions will be available. FDA staff work with the Office of Management and Budget (OMB) to update and renew the expired form(s) for posting on the FDA Forms webpage. The forms posted on this webpage may be used even if they appear to have an expiration date that has passed. 

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

2/26/2019 - Quality Considerations for Continuous Manufacturing Guidance for Industry