Do TNF Inhibitors Offer CV Benefits in Psoriasis, Psoriatic Arthritis?

In a study published in Clinical Reviews in Allergy & Immunology, researchers found that tumor necrosis factor (TNF inhibitors appeared to have clinical benefits with regard to adverse cardiovascular events in psoriasis and/or psoriatic arthritis.

Study Sheds Light on Link Between Immunotherapy and Arthritis Onset

A new study has shed light on an association between immune checkpoint inhibitors (ICIs) and the onset of inflammatory arthritis and sicca syndrome.

Hypertension, Pain Combo Drug Shown Beneficial on Kidney Function

Kitov Pharmaceuticals announced new study data from the Phase 3 study for KIT-302 (amlodipine besylate/celecoxib) in the treatment of osteoarthritis pain and hypertension, suggesting beneficial effects on renal function.

Does Prior TNFi Use Affect Secukinumab Effectiveness in Psoriatic Arthritis?

Secukinumab, a human anti-IL-17A monoclonal antibody, was shown to be effective in both tumor necrosis factor inhibitor (TNFi)-naïve and TNFi-exposed psoriatic arthritis patients, however greater improvements were noted in TNFi- naïve patients.

Higher Allopurinol Dose May be Nephroprotective in Elderly

A higher allopurinol dose provided a protective effect against incident renal failure in elderly patients, according to a study published in Annals of the Rheumatic Diseases.

Tocilizumab vs. Methotrexate Compared in Newly Diagnosed RA Patients

Immediate initiation with tocilizumab with or without methotrexate was more effective than methotrexate alone for patients with newly diagnosed rheumatoid arthritis, researchers concluded in a study published in The Lancet.

FDA to Review Deflazacort for Duchenne Muscular Dystrophy

Marathon Pharmaceuticals announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for deflazacort for the treatment of patients with Duchenne Muscular Dystrophy (DMD).

Oral Baricitinib Evaluated in RA Unresponsive to Conventional DMARDs

Eli Lilly and Incyte announced positive data from the pivotal study, RA-BEYOND, evaluating baricitinib vs. placebo for the treatment of rheumatoid arthritis (RA). Study findings were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.

Carpal Tunnel Function, Dexterity Improved With Electroacupuncture

Electroacupuncture may be a beneficial treatment option for carpal tunnel syndrome, according to a study published online June 6 in CMAJ, the journal of the Canadian Medical Association.

Sirukumab Inhibits Joint Destruction, Improves RA Symptoms, Study Shows

Janssen announced positive results from the SIRROUND-D study, a pivotal Phase 3 trial evaluating subcutaneous sirukumab (CNTO 136) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Biologics May Improve Fatigue in Rheumatoid Arthritis

For patients with rheumatoid arthritis (RA), biological interventions of both anti-tumor necrosis factor (anti-TNF) and non-anti-TNF agents may lead to a small to moderate improvement in fatigue.

Promising Results for Xeljanz as Potential Psoriatic Arthritis Tx

Pfizer announced top-line results from the OPAL Beyond study, the second Phase 3 trial of Xeljanz (tofacitinib citrate) for the potential treatment of patients with active psoriatic arthritis (PsA).

Cannabinoids May Benefit Pain, Sleep Issues For Rheumatic Patients

Cannabinoids may have limited benefits in rheumatic conditions, with some potential benefit in terms of pain relief and effect on sleep, according to a review published in Arthritis Care & Research.

Adherence Rates for Combination Therapies in RA Compared

Veterans with rheumatoid arthritis were significantly more likely to be persistent and adherent to a tumor necrosis factor inhibitor (TNFi) plus methotrexate combination therapy than to triple therapy with non-biologic disease-modifying antirheumatic drugs (DMARDs), a study published in Arthritis Care & Research concluded.

FDA Continues Review of Controversial DMD Treatment

Sarepta announced that the Food and Drug Administration (FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

Biosimilar Candidate to Remicade Under FDA Review

The FDA has accepted for review the Biologics License Application (BLA) for SB2 (Samsung Bioepis), a biosimilar candidate to Remicade (infliximab; Janssen), for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Risk Factors for Bisphosphonate-Associated Fractures, Osteonecrosis ID'd

Use of bisphosphonates is associated with adverse drug reactions such as atypical femoral fractures (AFs) and osteonecrosis of the jaw (ONJ).

Which Fluoroquinolone Antibiotic Carries the Greatest Risk of Tendinopathy?

Given the widespread use of fluoroquinolone antibiotics, clinicians should be aware of factors that may put patients at increased risk for tendinitis or tendon rupture, according to an article published in Pharmacotherapy.

Preventing Anemia After Orthopedic Surgery: The Role of Iron, ESA Pharmacotherapy

The use of intravenous (IV) or oral iron with or without an erythropoiesis-stimulating agent (ESA) may help prevent post-operative anemia and reduce blood transfusion without significantly raising the risk of adverse events, study authors reported in a study published in Annals of Pharmacotherapy.

FDA Grants Priority Review to Advanced Soft Tissue Sarcoma Tx

The FDA has granted Priority Review for the Biologics License Application (BLA) for olaratumab (Lilly), in combination with doxorubicin, for the potential treatment of advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.

FDA Advisory Committee Votes Against DMD Drug Approval

A majority of The Food and Drug Administration's (FDA) Advisory Committee voted against recommending eteplirsen, which in its New Drug Application (NDA), proposes to become the first drug to treat Duchenne muscular dystrophy.

Gene Variant Linked to Severe Cutaneous Reactions with Gout Treatment

Findings from a new study published in Seminars in Arthritis and Rheumatism show significant racial disparities in the risk of gout patients developing a serious, sometimes fatal adverse reaction to urate-lowering drugs.

REMS Requirement Removed for Gout Drug

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Krystexxa (pegloticase; Horizon) Injection.

New Biosimilar Inflectra Gets FDA Approval

The Food and Drug Administration (FDA) has approved Inflectra (infliximab-dyyb; Celltrion) for injection, a biosimilar to Remicade (infliximab; Janssen).

Certain ADHD Drugs May Lower Bone Density

Youth who take stimulants to treat attention deficit hyperactivity disorder (ADHD) may have a lower bone density than their peers who do not take stimulants, according to a study presented at ENDO 2016.

Certain Antidepressants May Up Bone Loss During Lactation

Selective serotonin reuptake inhibitors (SSRIs) use during pregnancy and lactation can result in decreased bone density in mothers, increasing their risk of fractures later in life, a study presented at ENDO 2016 has found.

Radius Submits NDA for New Osteoporosis Tx in Postmenopausal Women

Radius Health announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for abaloparatide-subcutaneous (SC) 80mg, a once daily treatment for postmenopausal women with osteoporosis.

Arthritis Patients May Be More Prone to Developing Periodontitis

Rheumatoid arthritis (RA) patients have a greater prevalence and severity of periodontitis than the non-arthritis population, according to a new study published in the Korean Journal of Internal Medicine.

Febuxostat vs. Allopurinol for the Prevention of Tumor Lysis Syndrome

The efficacy and safety of febuxostat was noninferior to allopurinol for preventing tumor lysis syndrome (TLS) in patients with malignant tumors about to receive chemotherapy, according to a new study published in the journal, Oncology.

Promising Results for Romosozumab in Men with Osteoporosis

Amgen and UCB announced positive top-line results from the pivotal Phase 3 study, BRIDGE, evaluating romosozumab for the treatment of osteoporosis in men.

Vaccination Recommendations for RA Patients on DMARD Therapy

Vaccination rates in patients with rheumatoid arthritis remain poor "despite the high rates of infectious disease-related morbidity and mortality," a review published in Clinical Opinion in Rheumatology has found.

Efficacy of NSAIDs Compared for Osteoarthritis Pain

Diclofenac 150mg per day was determined as the most effective non-steroidal anti-inflammatory drug (NSAID) available for improving both pain and function in patients with osteoarthritis, according to a study published in The Lancet.

Corticosteroid Injection Currently in Shortage

The FDA is reporting a shortage in certain presentations of Solu-Medrol Powder for Injection (Pfizer) and the generic Methylprednisolone sodium succinate for injection (Fresenius Kabi).

Investigational Treatment Shows Superiority in RA Study

Regeneron and Sanofi announced their Phase 3 study for sarilumab has met its primary endpoint, demonstrating superiority over adalimumab in improving symptoms in patients with active rheumatoid arthritis (RA) at Week 24, in the SARIL-RA-MONARCH trials.

Study Tests Potential Benefits of Vitamin D Supplementation in Knee Osteoarthritis

For patients with knee osteoarthritis, supplementation with vitamin D does not slow cartilage loss or alleviate knee pain.

Long-Term Safety Data for Otezla Announced

Celgene announced long-term safety data for Otezla (apremilast) from ongoing clinical trials at the American Academy of Dermatology's Annual Meeting.

Study Reveals Negative BMD Association With ADHD Meds in Adolescents

A significant difference in bone mineral density (BMD) was noted in patients aged 8-17 who have used ADHD medication, compared to their same aged counterparts who have not taken the medication.

Survey Reveals Docs Prescribing Preferences for Osteoporosis Tx

A recent online survey has found that physicians in the United States tend to prefer weekly or monthly regimens when prescribing treatment for patients with osteoporosis.

Top-Line Results for Investigational Osteoporosis Tx Announced

Amgen and UCB announced top-line results from the Phase 3 FRAME study evaluating the safety and efficacy of romosozumab for the treatment of osteoporosis in postmenopausal women.

Osteoporosis Tabs Recalled Due to Unknown Impurity Levels

Sun Pharma announced a recall of Alendronate Sodium Tablets 70mg, the generic version of Fosamax.

Third Orphan Drug Designation Granted to TXA127 in Muscular Dystrophy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to TXA127 (Tarix Orphan) for the treatment of laminin-deficient congenital muscular dystrophy (LAMA2 MD or MDC1A).

Glucosamine, Chondroitin Sulfate Provides Long-Term Protection in Knee OA

Findings from a recent study published in Arthritis Care & Research support the long-term protective effects of glucosamine/chondroitin sulfate on the progression of structural changes in knee osteoarthritis.

Vivlodex Now Available for Osteoarthritis Pain

Iroko announced that Vivlodex (meloxicam) capsules is now available for the management of osteoarthritis (OA) pain.

Xeljanz Released from REMS Requirement

The FDA has approved a supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib; Pfizer) to eliminate the requirement for the approved Risk Evaluation and Mitigation Strategy (REMS) assessment.

Advisory Panel Recommends Approving Biosimilar of Remicade

Celltrion announced that the Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all indications for CT-P13, a biosimilar candidate of Remicade (infliximab; Janssen Biotech).

New Dosage Strength of Xeomin Launched

Merz Neurosciences announced the launch of Xeomin (incobotulinumtoxinA) in a new 200 Unit single-dose vial.

New Study Proposes Strategies for Pain Control After Total Knee Replacement

A team-based care approach comprised of the patient, family members, orthopedic surgeon, and other healthcare practitioners for total knee replacement procedures, combined with newer pain management strategies, is critical for maximizing patient outcomes.

BLA for Adalimumab Biosimilar Accepted for Review

Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

Study Shows Majority of Gout Patients Unaware of Treatment Goals

A new study has highlighted a possible knowledge-gap between healthcare professionals and gout patients, concerning their condition.

Botox Gains Lower Limb Spasticity Indication

Allergan announced that the Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adults to decrease the severity of increased muscle stiffness in ankle and toe muscles.

Guidance on Long-Term Bisphosphonate Tx for Osteoporosis Issued

A task force of the American Society for Bone and Mineral Research has issued guidance on the bisphosphonate therapy for osteoporosis with a risk-benefit perspective.

FDA to Review Once-Daily Oral RA Tx

Eli Lilly and Incyte announced that the New Drug Application (NDA) for once-daily oral baricitinib has been submitted to the Food and Drug Administration (FDA) for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

Cosentyx Gains Two New Arthritis Indications

Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

FDA Issues Complete Response Letter to Kyndrisa

The Food and Drug Administration (FDA) has issued a Complete Response Letter to the New Drug Application (NDA) for Kyndrisa (drisapersen; Biomarin), for the treatment of Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping.

Cancer, RA Biosimilars Demonstrated Efficacy in Phase 3 Trials

Sorrento Therapeutics announced that its partner, MabTech, has successfully completed Phase 3 clinical trials in China for STI-001, a biosimilar antibody for cetuximab (Erbitux).

NDA for First-in-Class DMD Tx Submitted to FDA

PTC Therapeutics announced the completion of its rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

Physicians Advised to Rethink Preference for Osteoporosis 'Drug Holiday'

The International Osteoporosis Foundation (IOF) has advised physicians to make treatment decisions more individualized for patients taking bisphosphonates; a class of drugs used to treat osteoporosis.

Xeomin Approved for Adult Upper Limb Spasticity

Merz North America announced that Xeomin (incobotulinumtoxinA) has been approved by the Food and Drug Administration (FDA) for the treatment of upper limb spasticity in adults.

New Gout Treatment Gets FDA Approval

The FDA has approved Zurampic (lesinurad; AstraZeneca) to treat hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).

For Active Individuals, Higher Vit D Levels May Be Needed

Individuals who participate in higher impact activities may require higher vitamin D levels to reduce their risk of stress fractures, a new study in The Journal of Foot & Ankle Surgery reported.

Lifetime Chronic Pain Can Result From Risks During Adolescence

Adolescents who have affective, anxiety, and behavioral disorders may be at increased risk for developing chronic pain, a new study published in The Journal of Pain has found.

FDA Grants Orphan Drug Designation to new Treatment for Duchenne Muscular Dysptrophy (DMD)

Food and Drug Administration (FDA) has granted Orphan Drug designation and Rare Pediatric Disease designation to ARM210 (also known as S48168) for the treatment of Duchenne Muscular Dystrophy (DMD)

USPSTF Calls for More Research in These 5 Women's Health Issues

The United States Preventive Services Task Force (USPSTF) released its annual Report to Congress reporting on 5 high-priority evidence gaps regarding women's health.

In Knee OA Study, Chondroitin Beats Common First-Line Tx in Disease Progression

Chondroitin sulfate was shown to be more effective in reducing long-term progression of knee OA than celecoxib.

Be on the Lookout for This Early Sign of Lyme Disease, Says Study

According to research published in The Journal of the American Academy of Orthopaedic Surgeons, spontaneous knee effusion can be a primary symptom of Lyme disease even without the presence of a "bull's eye" rash.

Mobic Oral Suspension No Longer Available

The decision to discontinue the product is business-related and not due to product safety or efficacy.

FDA Arthritis Committee Recommends Lesinurad Approval

AstraZeneca announced that the FDA Arthritis Advisory Committee (AAC) has recommended the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

Vivlodex Approved for Osteoarthritis Pain

Iroko announced that the Food and Drug Administration (FDA) has approved Vivlodex (meloxicam), a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.

New Data on First-in-Class Duchenne Muscular Dystrophy Tx

PTC Therapeutics announced positive results from the Phase 3 ACT DMD trial of Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

Investigational Oral Arthritis Tx Tops Adalimumab in Phase 3 Study

Eli Lilly and Incyte announced positive topline results of RA-BEAM, the fourth Phase 3 study of baricitinib for patients with moderately-to-severely active rheumatoid arthritis (RA).

Long-Term BMD Gain With Prolia Shown in 10-Year Study Data

Amgen announced results from a 7-year, single-arm, open-label extension of the 3-year randomized, double-blind, placebo-controlled, multi-center, international Phase 3 FREEDOM Study.

Supartz FX Injection Launched for Knee Osteoarthritis Pain

Bioventus announced the launch of Supartz FX (hyaluronic acid) for the management of knee osteoarthritis pain.

New Duchenne Muscular Dystrophy Tx Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to TXA127 (angiotensin 1-7; Tarix Orphan) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.

Infants Born to Mothers Exposed to This HIV Drug May Have Lower Bone Mass

According to a National Institutes of Health (NIH) Study, infants exposed in the womb to the HIV drug tenofovir disoproxil fumarate, may have lower bone mineral content than those exposed to other anti-HIV drugs.

Study: Baricitinib Superior to Conventional DMARD

Eli Lilly and Incyte announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib for the treatment of patients with moderately-to-severely active rheumatoid arthritis (RA).

New Recommendations Released for Treating Ankylosing Spondylitis, Spondyloarthritis

The American College of Rheumatology, in conjunction with the Spondylitis Association of America and the Spondyloarthritis Research and Treatment Network, has released new recommendations for both pharmacologic and non-pharmacologic treatment of ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (SpA).

Keveyis Launched for Primary Periodic Paralysis

Taro announced the launch of Keveyis (dichlorphenamide) tablets, the first therapy approved for the treatment of primary hyperkalemic and hypokalemic periodic paralysis and related variants.

ColciGel for Acute Gout Flares Now Available

Gensco Laboratories announced the launch of ColciGel (colchicinum 4X) indicated for the treatment and prophylaxis of acute gout flares in adults, the first prescription transdermal gel approved for this condition.

New PMR Screening, Tx Recs and Gout Classification Criteria

The American College of Rheumatology (ACR), in collaboration with the European League Against Rheumatism, has issued new publications on recommended screening, treatment, and management of polymyalgia rheumatica (PMR) and new classification criteria for gout.

Bone Fracture, Density Warning Issued for SGLT2 Inhibitor

The Food and Drug Administration (FDA) has issued another warning for canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, regarding the risk for bone fractures with new information about decreased bone mineral density.

Exercise May Lower Fracture Risk With Rosiglitazone

Research in the journal Endocrinology indicates that exercise may partially reduce the risk of increased marrow adipose tissue associated with both diabetes and peroxisome proliferator-activated receptor agonists (PPARs) medications for the treatment of type 2 diabetes.

Epidural Steroid Injections May Be Effective for Spinal Stenosis After All

Contrary to a study published in the New England Journal of Medicine (NEJM) which concluded that epidural steroid injections were not helpful in the treatment of lumbar spinal stenosis, a letter in the journal Pain Medicine states that epidural steroid injections may provide good short term benefit, lasting from weeks to months.

Top-Line Results for Investigational Osteoporosis Drug

Amgen and UCB announced top-line results from the STRUCTURE trial evaluating romosozumab in women with postmenopausal osteoporosis at high risk for fracture previously treated with bisphosphonate therapy.

FDA Approves Updated Labeling for Simponi Aria

Janssen Biotech announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the label for Simponi Aria (golimumab for infusion) to include measures in both physical and emotional health in patients being treated for moderately to severely active rheumatoid arthritis (RA).

Novel Drug Granted Orphan Designation for Rare Musculoskeletal Disorder

The Food and Drug Administration (FDA) has granted AT001 (Audentes) Orphan Drug designation for the treatment of X-Linked Myotubular Myopathy (XLMTM).

Tomatoes as Gout Trigger? New Study Adds to Evidence

Patients with gout often self-report foods like tomatoes and tomato products as dietary triggers, but consumption of these foods as a trigger of gout flares may not be supported by empirical evidence. A study in BMC Musculoskeletal Disorders reports on a positive association between tomato consumption and serum urate levels, but suggests that there may be a biological basis.

First Drug Approved for Primary Periodic Paralysis

Taro announced that the Food and Drug Administration (FDA) has approved Keveyis (dichlorphenamide) tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis.

When Supplement Use Becomes an Eating Disorder

Recent research has shown that an increasing number of men are using over-the-counter bodybuilding supplements to the point where it may be characterized as an eating disorder.

Vitamin D May Not Benefit Postmenopausal Women

Postmenopausal women did not experience beneficial effects on bone mineral density, muscle function, muscle mass or falls with high-dose vitamin D, according to a study published in JAMA Internal Medicine.

Do Antibiotics Increase Juvenile Arthritis Risk?

New research in Pediatrics suggests that children who are exposed to antibiotics could have an increased risk of newly diagnosed juvenile idiopathic arthritis (JIA), but that antibiotic use could be a marker for abnormal immunity rather than a direct cause of JIA.

Arthritis Drug May Help Eczema Patients, Too

A drug used to treat rheumatoid arthritis (RA) was effective in patients with moderate to severe eczema, according to a study conducted by researchers from Yale School of Medicine.

Dysport Gains FDA Approval for Upper Limb Spasticity

Ipsen announced that the Food and Drug Administration (FDA) has approved Dysport (abobotulinumtoxinA) injection for the treatment of upper limb spasticity in adults.

Certain Comorbid Disorders May Lower Opioid Efficacy, Up Abuse Risk

Opioids are often prescribed to treat chronic lower back pain, but patients with comorbid psychiatric disorders such as depression and anxiety could experience significantly less pain relief with this therapy and may be more likely to abuse their medication.

Diazepam Sold Online May Actually Be Antipsychotic, FDA Warns

The Food and Drug Administration (FDA) issued a warning about the potential risk of purchasing counterfeit diazepam online.

FDA to Review New Xeljanz Formulation for Rheumatoid Arthritis

Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.

Eteplirsen NDA Submission Completed for Duchenne Muscular Dystrophy

Sarepta Therapeutics announced that it has completed a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for eteplirsen.

Cosentyx Efficacious in Psoriatic Arthritis Study

Novartis announced one year results from the Phase 3 FUTURE 2 study with Cosentyx (secukinumab) in patients with psoriatic arthritis (PsA).

Are Americans Following Physical Activity Guidelines?

Results from the National Health Interview Survey show that between 2008 and 2013, the percentage of people meeting the Department of Health and Human Services 2008 Physical Activity Guidelines for Americans increased for all age groups.

Women Wishing to Conceive May Want to Avoid These Pain Meds, Study Suggests

A study presented at the European League Against Rheumatism Annual Congress (EULAR 2015) indicates that use of some non-steroidal anti-inflammatory drugs (NSAIDs) could have a negative impact on female fertility, even with short-term use.

Mylan Expands Recall of Multiple Injectable Products

Mylan announced that it is expanding a voluntary recall of multiple injectable products to the hospital/user level due to the presence of visible foreign particulate matter.