Categorynews

Yaral Pharma Launches Diclofenac Epolamine Topical System 1.3%

January 3, 2023 Off By BusinessWire

Authorized Generic of Flector® Now Available

PARSIPPANY, N.J.–(BUSINESS WIRE)–Yaral Pharma Inc., the US generics subsidiary of IBSA, a long-standing, multinational pharmaceutical company headquartered in Lugano, Switzerland today announced the launch of diclofenac epolamine topical system 1.3%, the authorized generic of IBSA Pharma’s Flector® (diclofenac epolamine) topical system. Diclofenac epolamine topical system 1.3% is a prescription nonsteroidal anti-inflammatory (NSAID) medicated patch indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

“We are excited to kick off the new year by launching the first of several products in our portfolio which includes authorized and complex generic medications,” said Stephen Beckman, CEO, Yaral Pharma. “Like Flector, Yaral Pharma’s diclofenac epolamine topical system 1.3% offers patients a non-opioid topical treatment backed by more than 30 years of clinical experience. We are pleased to offer patients an accessible and affordable product that offers targeted topical pain relief and look forward to expanding our product line across a range of therapeutic areas in the months ahead.”

Yaral Pharma’s diclofenac epolamine topical system 1.3% patch (NDC 82347-0405-5) is currently available to order. For questions about ordering, contact Yaral Pharma at 1-866-218-9009.

Yaral Pharma has begun commercializing IBSA Pharma’s authorized generics and is poised to rapidly expand its product line organically through outside opportunities and external partnerships with a focus on oral solid dosage (OSD), complex and 505(b)2 products. The Company’s current portfolio includes products in the therapeutic areas of pain and endocrinology with future expansion planned in the areas of rheumatology, fertility/women’s health, dermatology/dermo-aesthetic, and ophthalmology. For the latest updates on Yaral Pharma, visit www.yaral-pharma.com or connect with us on LinkedIn.

Product Information

Product

Strength

NDC #

Package Size

Diclofenac epolamine topical system

1.3%

82347-0405-5

One Carton = 30 patches

To order, please call Yaral Pharma at 1-866-218-9009.

Please refer to the full Prescribing Information, including Boxed Warning for diclofenac epolamine topical system, 1.3% here.

You are encouraged to report suspected adverse reactions to Yaral Pharma by emailing [email protected] or calling 866-218-9009 or to the FDA by visiting http://www.fda.gov/medwatch.

     
 

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

 

Cardiovascular Thrombotic Events

 

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
  • Diclofenac epolamine topical system 1.3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

 

Gastrointestinal Bleeding, Ulceration, and Perforation

 

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
 
 

About Authorized Generics

According to the U.S. Food and Drug Administration, the term “authorized generic” drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. The product the patient receives is identical to the branded product, contains the same active and inactive ingredients, and is manufactured using the same process at a considerable cost savings.

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.yaral-pharma.com or contact [email protected] or 866-218-9009.

Flector® is a registered trademark of IBSA Institut Biochimique S.A.

Contacts

Daina Basile

Kovak-Likly Communications

203-762-8833, [email protected]