Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
January 31
N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel - a randomized clinical trial   Is the use of N95 respirators or medical masks more effective in preventing influenza infection among outpatient health care personnel in close contact with patients with suspected respiratory illness?  Among outpatient health care personnel, N95 respirators vs medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza.

Today the U.S. Food and Drug Administration approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia may be initiated in individual's ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. Those who take Palforzia must continue to avoid peanuts in their diets.  Peanut allergy is a condition in which the body's immune system mistakenly identifies even small amounts of peanut as harmful.

FDA Warns Maker of Nicotine Containing Toothpicks of Several Violations including illegal Sales.  "The FDA has been holding retailers and manufacturers accountable for marketing and sales practices that have led to increased youth accessibility and appeal of tobacco products. We're especially concerned about novel nicotine-containing products, such as these nicotine-containing toothpicks, being sold and marketed to youth. Evidence shows that youth exposure to nicotine can adversely affect the developing adolescent brain and put youth at risk for nicotine addiction.
January 29
Warning Letters
Douglas Howard, CEO; Evig LLC dba Balance of Nature, St. George, UT 84790
During our inspection, we reviewed labeling on your firm's website at and your YouTube channel. The inspection revealed serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. The claims on your product labeling, including your website and YouTube channel, establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ยง 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. One example of numerous: "One of the best things about these [Balance of Nature products] is people with asthma, they say it goes away."

Ana R. Marx, Managing Member, Marco Pharma Int'l LLC Roseburg, OR 97470
The inspection of your facility revealed serious violations of FDA's regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adultrated because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. One example of numerous: You failed to establish the required specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
January 28
FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can lead to serious bowel problems.  Risk increased at higher doses or when taken with other constipating medicines.  It produces effects ranging from constipation (trouble having a bowel movement), which is a common occurrence, to serious but uncommon bowel problems, including complete blockage of the bowels.  Other symptoms: their bowel movements are less frequent than normal, they do not have a bowel movement at least three times a week, they have hard or dry stools, and they have difficulty passing gas.  Patients should their physician if they experience nausea, vomiting, or bloating or belly swelling, or belly pain.
January 27
Guidance for Industry  
Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry
January 23
All lots of dietary supplement products by ABH Nature's Products, ABH Pharma and Recall. All dietary supplement products manufactured and sold between January 2013 to November 2019 are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations.
January 21
The U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease.   This is a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). Today's approval represents the first drug approved for the treatment of thyroid eye disease.  Tepezza was approved based on the results of two studies (Study 1 and 2) consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo. Of the patients who were administered Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than 2 millimeter reduction in proptosis (eye protrusion) as compared to 20% and 10% of subjects who received placebo, respectively.

Shedding More Light on Sunscreen Absorption    A clinical study evaluated the absorption of a wide range of sunscreen active ingredients after a single use.  While additional data are needed, results showed that all six of the active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate) were absorbed into the body's bloodstream. The findings in these studies do not mean that the FDA has concluded that any of the ingredients tested are not safe for use in sunscreens, nor is the FDA seeking further information to indicate such.  Absorption does not equal risk, but this finding is unsettling.  The FDA advises continued use of sunscreens.  Now the two active ingredients that are generally recognized as safe are zinc oxide and titanium dioxide.
January 14
Exposure to Common Insecticides Associated with Risk of Death.  People with higher exposures to common insecticides called pyrethroids had an increased risk of death in the years following the measurements. Pyrethroids have been considered relatively safe for people.  Pyrethroid pesticides are the second-most commonly used class of insecticides in the world. In addition to use in agriculture, pyrethroids are widely applied for pest control in public spaces and in homes. They play an important role in preventing the spread of insect-borne diseases, such as the West Nile and Zika viruses. People are exposed to pyrethroids mainly through food, such as fruits and vegetables that have been sprayed with them, and dust in households that apply pyrethroids for pest control.  The association between pyrethroid exposure and overall risk of dying was stronger among obese individuals.

Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.

Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin).   At this time, the cause of the cancer is uncertain, and the FDA cannot conclude that lorcaserin contributes to the cancer risk. However, they wanted to make the public aware of this potential risk. The FDA is continuing to evaluate the clinical trial results and will communicate their final conclusions and recommendations when they have completed their review.
January 9
Nizatidine Capsules by Mylan: Recall Due to Detected Trace Amounts of NDMA Impurity Found in the Active Pharmaceutical Ingredient (API) Nizatidine Capsules 150 mg Lot 3086746 and Nizatidine Capsules 300 mg, Lots 3082876 and 3082877 are effected by the recall.  They were manufactured by Solara Active Pharma Sciences Limited.     Nitrosodimethylamine (NDMA) has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).

Stopping infections before they happen through safer endoscope reprocessing.  Research has shown that biofilm can build up inside endoscopes over time, making current cleaning and disinfection procedures (called "reprocessing") less effective.   Recently, the Biofilms Research Group in the Center for Devices and Radiological Health's Office of Science and Engineering Laboratories has developed tools (called "FDA Quicker") that can tell hospitals how clean an endoscope is after reprocessing.  These tools can detect and quantify miniscule amounts of contamination, much lower than anything currently commercially available.
January 8
The Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.)   It is used to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. For more information click here.

Ranitidine Hydrochloride Capsules by Appco Pharma: Recall Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) They are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests.
January 7
Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards; February 19; Silver Spring MD; Live webcast available Control/Click on title for more information.
January 6
FDA Warns About Serious Breathing problems With Seizure and Nerve Pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR).   The FDA is  requiring new warnings about the risk of respiratory depression be added to the prescribing information of the gabapentinoids and have required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids. Misuse and abuse of these products together is increasing and may increase the risk of respiratory depression.  The elderly are also at higher risk.
January 3
Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength.  Bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.  Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.