Only Other Oral Erythromycin Tablet Received FDA Approval


Amneal Pharmaceuticals received approval for sales of Erythromycin Tablets USP, 250 mg and 500 mg strengths, on March 14, 2018.

Amneal Pharmaceuticals— a privately-held company, which is one of the largest generics pharmaceutical manufacturers in the U.S.—received FDA approval for Erythromycin Tablets USP, 250 mg and 500 mg strengths.  The product developed by Amneal, which just received U.S. FDA approval, is a therapeutic equivalent for the reference listed drug (RLD) Erythromycin Tablets that is originally developed by Arbor Pharmaceuticals. The new approval made the new drug the only other immediate release oral tablet of Erythromycin available to the masses.

Andy Boyer, Amneal EVP-Commercial Operations said, “Amneal is committed to increasing access to affordable medications. Erythromycin tablets are a great example of a product with limited availability where we can now provide patients and pharmacists with options.”

The company is selling the drug in a 100-count bottles and are available to wholesalers, distributors, and direct to the trade. Annual sales in the U.S. for erythromycin tablets recorded US$ 84 million, as revealed by the company.

The company functions globally cross North America, Asia, and Europe, and aims at providing high quality medicines to patients at affordable prices worldwide. Amneal significantly expanded its generic product portfolio to include complex dosage forms in a broad range of therapeutic areas.

Amneal Pharmaceuticals LLC entered into a business collaborative agreement with Impax Laboratories, Inc. on October 17, 2017. The combined entity was expected to create the 5th largest generics business in the U.S., the transaction of which is expected to close by the first half of 2018.


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