Mayne Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval of its Abbreviated New Drug Application (ANDA) for doxycycline hyclate immediate release (IR) tablets (75 mg and 150 mg). Mayne Pharma has immediately commenced commercial launch to customers in the United States.
Doxycycline hyclate IR tablets are a generic version of Acticlate® tablets, a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne. According to IMS Health, annual sales of Acticlate® in the United States were approximately $250 million for the 12 months ending April 2017.
Mayne Pharma’s CEO Scott Richards said, “We are very pleased to have launched the first generic alternative to Acticlate® in the United States and to provide more choices to patients and payers in terms of medication affordability. Today’s approval exemplifies Mayne Pharma’s commitment to bringing first-to-market generic products to the marketplace.”
The launch of doxycycline hyclate IR tablets is Mayne Pharma’s fourth first-to-market generic launch since June 2016 after dofetilide capsules, butalbital acetaminophen tablets (50 mg/300 mg) and methylphenidate extended-release capsules (60 mg).