Another First ANDA for Spear Pharmaceuticals

July 31, 2013 – Spear Pharmaceuticals, Inc. (Spear) announces that it has received U.S. Food and Drug Administration approval for its Abbreviated New Drug Applications (ANDAs) for Tretinoin gel, USP (Microsphere) 0.1% and 0.04%, the generic equivalent to Retin-A Micro®, on July 17, 2013. The ANDA approvals were based on two double-blinded, placebo-controlled trials that proved bioequivalent in efficacy and safety. Spear Dermatology Products, Inc., the sales and marketing arm of Spear Pharmaceuticals, Inc., will sell the product.

Tretinoin gel, USP (Microsphere) 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris.1 Acne is the most common skin condition in the United States, affecting 40 million to 50 million Americans.2 Nearly 85% of all people have acne at some point in their lives, most often on the face, chest, and back.2

“We are proud to launch these first generics for Retin-A Micro® proven by large bioequivalent acne studies,” said K.L. Spear M.D., President of Spear Pharmaceutical’s, Inc. “This is our 8th first generic approval, the others include the 3 strengths of Retin-A® Cream and 2 strengths of Retin-A Gel®, Renova® 0.05%, and Efudex® 5%.”

 

Safety Information

Product in some patients may cause redness, itching, burning, stinging and peeling. If the degree of irritation warrants, patients should be advised to use less medication and decrease the frequency of application. If still significant, discontinue.

 

About Spear Pharmaceuticals, Inc. and Spear Dermatology Products, Inc. 

Spear Pharmaceuticals, Inc. is a specialty dermatology company that develops bioequivalent and branded products that help people restore their skin’s health. Our products are manufactured in the United States in facilities inspected and approved by the FDA. Every Spear Pharmaceuticals product is FDA approved and meets the highest standards of quality.

Spear Dermatology Products, Inc. commercializes products developed by Spear Pharmaceuticals. All of Spear’s products are manufactured in the United States in facilities inspected and approved by the FDA. Products marketed over the last decade include those used in the treatment of acne, actinic keratosis, superficial basal cell carcinoma, fine facial wrinkles, tactile roughness of the skin, and hyperpigmentation. Spear is committed to the ongoing commitment of developing products that help patients restore their skin’s health.

 

For further information:

Michael Langer

langer@spearpharma.com

 

Retin-A Micro® is a registered trademark of Ortho-McNeil Pharmaceuticals, Inc.

 

1. Tretinoin gel, USP (Microsphere) 0.1% and 0.04% Full Prescribing Information. Spear Pharmaceuticals.

2. American Academy of Dermatology. Accessed July 17, 2013. Available at: http://www.aad.org/media-resources/stats-and-facts/conditions/acne#.UeaRTFOE7vo