TEVA PHARMACEUTICAL INDUSTRIES, LTD: Announces US Launch of a Generic Version of Elidel®(Pimecrolimus) Cream, 1%

Teva Pharmaceutical Industries. LTD issued the following announcement on Dec. 27.

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of a generic version of Elidel®1 (pimecrolimus) Cream, 1% in the U.S.

Pimecrolimus Cream, 1% is a topical prescription medicine to be used as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

Brendan O’Grady, EVP and Head of North America Commercial at Teva said, “We’re proud to offer another affordable treatment option. This launch represents an important addition to our generics portfolio and underscores our commitment to ensuring that patients have more treatment options.”

With over 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Elidel® Cream, 1% had annual sales of approximately $218.4 million in the US, according to IQVIA data as of October 2018.

About Pimecrolimus Cream, 1%

Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

IMPORTANT SAFETY INFORMATION

WARNING: Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age.

Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Pimecrolimus Cream, 1% should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications. The use of pimecrolimus cream, 1% should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis. Pimecrolimus Cream, 1% should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of Pimecrolimus Cream, 1% has not been established in patients with generalized erythroderma.

Before commencing treatment with Pimecrolimus Cream, 1%, bacterial or viral infections at treatment sites should be resolved. The use of Pimecrolimus Cream, 1% may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while Pimecrolimus Cream, 1% is not on the skin. The potential effects of Pimecrolimus Cream, 1% on skin response to ultraviolet damage are not known.

In clinical trials, cases of lymphadenopathy were reported while using Pimecrolimus Cream, 1%. The safety and efficacy of Pimecrolimus Cream, 1% in immunocompromised patients have not been studied. In clinical trials, the most commonly reported adverse reactions (greater than or equal to 1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection.

For more information, please see accompanying Full Prescribing Information, including Boxed Warning. A copy may be requested from Teva US Medical Information at 888-4-TEVA-USA (888-838-2872) or druginfo@tevapharm.com, or Teva’s Public Relations or Investor Relations contacts.

Original source can be found here.