YARAL Pharma Now The Exclusive Supplier Of Authorized Generic Levothyroxine Sodium Capsules In The U.S. Market

FOR IMMEDIATE RELEASE

YARAL PHARMA NOW THE EXCLUSIVE SUPPLIER OF AUTHORIZED GENERIC LEVOTHYROXINE SODIUM CAPSULES IN THE U.S. MARKET

Parsippany, NJ – July 9, 2024 – YARAL Pharma Inc. (YARAL Pharma), the U.S. generics subsidiary of IBSA (Institut Biochimique SA), a multinational pharmaceutical company headquartered in Lugano, Switzerland, today announced that they are now the exclusive supplier of the authorized generic levothyroxine sodium capsules in the United States. Levothyroxine Sodium Capsules are used to treat hypothyroidism.

“When it comes to managing hypothyroidism, not all levothyroxine medications are created equal,” said Stephen Beckman, CEO of YARAL Pharma. “Each year, millions of patients are treated with levothyroxine. For those who have trouble tolerating traditional levothyroxine tablets, the answer may lie in the dosage form. YARAL is pleased to offer patients a high-quality gel capsule product, specially formulated to improve the tolerability of LT4 therapy, supported by continuity of supply, and an exceptional level of customer service.”

YARAL Pharma’s Levothyroxine Sodium Capsules, a unique gel-cap formulation designed to address concerns of absorption and tolerability commonly found in levothyroxine tablets are available in twelve dosage strengths. The capsules contain only four simple ingredients: levothyroxine, gelatin, glycerin and water, and are free from sugars, dyes, alcohol, wheat starch (gluten), and lactose.1 This is especially important for patients with hypothyroidism who have allergies or sensitivities to ingredients commonly found in levothyroxine tablets or for those with certain gastrointestinal conditions.2

To order YARAL Pharma’s Levothyroxine Sodium Capsules, click here or contact YARAL Pharma customer service at 866-218-9009.

For Full Prescribing Information, including Boxed Warning, visit www.yaralpharma.com/levothyroxine-pi. 

To report SUSPECTED ADVERSE REACTIONS, contact YARAL Pharma Inc. at 866-218-9009 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS
  • Thyroid hormones, including Levothyroxine Sodium Capsules, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
  • In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
  • Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

INDICATIONS AND USAGE
Hypothyroidism primary (thyroidal). Secondary Levothyroxine Sodium Capsules is indicated as a replacement therapy in adults and pediatric patients 6 years and older with (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine Sodium Capsules is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer.

CONTRAINDICATIONS

  • Uncorrected adrenal insufficiency

WARNINGS AND PRECAUTIONS

  • Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease. Initiate Levothyroxine Sodium Capsules, at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.
  • Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma.
  • Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of Levothyroxine Sodium Capsules, treatment.
  • Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism.
  • Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy.
  • Decreased bone mineral density associated with thyroid hormone over-replacement. Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose.
  • Use for the suppression of nontoxic diffuse goiter or nodular thyroid disease: Use is not recommended in iodine-insufficient patients.

LIMITATIONS OF USE

  • Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients,
  • Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

ADVERSE REACTIONS
Common adverse reactions with levothyroxine therapy are primarily those of hypothyroidism due to therapeutic overdosage. They include the following:

  • General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
  • Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
  • Musculoskeletal: tremors, muscle weakness
  • Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
  • Respiratory: dyspnea
  • Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests
  • Dermatologic: hair loss, flushing
  • Endocrine: decreased bone mineral density
  • Reproductive: menstrual irregularities, impaired fertility

ADVERSE REACTIONS IN CHILDREN
Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height. Seizures have been reported rarely with the institution of levothyroxine therapy.

HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions to inactive ingredients (in this product or other levothyroxine products) have occurred in patients treated with thyroid hormone products. These include urticaria, pruritis, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

For Full Prescribing Information, including Boxed Warning, visit www.yaralpharma.com/levothyroxine-pi. 

To report SUSPECTED ADVERSE REACTIONS, contact YARAL Pharma Inc. at 866-218-9009 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About YARAL Pharma
YARAL Pharma Inc. (Parsippany, NJ) is the US generics subsidiary of IBSA, a global pharmaceutical company headquartered in Switzerland. By focusing on people and innovating the ways they’re cared for, YARAL Pharma is proud to offer the same values and expertise of its parent company to the US market. Dedicated to ensuring access to affordable authorized generics (AGs) and complex generic medicines that enhance healthcare outcomes, YARAL Pharma offers its customers high-quality products across a range of therapeutic areas, continuity of supply, and a commitment to exceptional customer service. For more information, visit www.yaralpharma.com or contact info@yaralpharma.com or 866-218-9009.

About IBSA
IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical Company, founded in 1945 in Lugano. Today, its products are present in over 90 Countries on 5 continents, through the Company’s 18 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 900 million CHF, and employs over 2,200 people between headquarters, subsidiaries and production sites. IBSA holds 90 families of approved patents, plus others under development, as well as a vast portfolio of products, covering 10 therapeutic areas: reproductive medicine, endocrinology, pain and inflammation, osteoarticular, aesthetic medicine, dermatology, uro-gynaecology, cardiometabolic, respiratory, consumer health. It is also one of the largest operators worldwide in the area of reproductive medicine, and one of the world’s leaders in hyaluronic acid-based products. IBSA has based its philosophy on four pillars: Person, Innovation, Quality and Responsibility.

References

  1. Levothyroxine Sodium Capsules [package insert]. Parsippany, NJ: YARAL Pharma Inc; 2021.
  2. McMillan M, Rotenberg KS, Vora K, et al. Comorbidities, concomitant medications, and diet as factors affecting levothyroxine therapy; results of the CONTROL Surveillance Project. Drugs in R&D. 2015;16(1):53-68.

Media Contact
Daina Basile
Kovak-Likly Communications
dbasile@klcpr.com

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