Teligent's topical erythromycin gel receives FDA approval

Teligent now has 19 topical generic pharmaceutical products in the U.S. | Contributed image

New Jersey-based specialty generic pharmaceutical manufacturing firm Teligent recently obtained U.S. Food and Drug Administration approval — its third in 2017 — for its Abbreviated New Drug Application (ANDA) regarding its Erythromycin Topical Gel USP, 2%.

In addition, the erythromycin go-ahead represents the company’s 14th such approval among its specialized internal product line for topic remedies.

According to data obtained from QuintilesIMS, a U.S.-based health information technology and clinical research firm headquartered in Durham, North Carolina, the product’s total “addressable market” is approximately $17.6 million.

"Erythromycin Topical Gel USP, 2% is Teligent's third FDA approval in 2017,'' Teligent President and CEO Jason Grenfell-Gardner said. "Teligent now has 19 topical generic pharmaceutical products in the U.S. portfolio, in addition to our four U.S. injectable products. We expect to launch this product in the third quarter of 2017."

Erythromycin is an antibiotic classified as a macrolide, named for its molecular structure, and is used to treat a variety of bacterial issues such as respiratory infections, dermatological conditions such as acne, and STDs. In additions to topical application, it can be taken orally or intravenously.

“Our mission is to be a leading player in the specialty generic prescription drug market,” Teligent officials said.

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Teligent, Inc. 105 Lincoln Ave Vineland, NJ - 08360-9228