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Australia : Mayne Pharma Announces FDA Approval and Immediate Launch of Doxycycline Hyclate IRTablets, First Generic to Acticlate.

Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Ad ministration (FDA) has granted approval of its Abbreviated New Drug Application (ANDA) for doxycycline hyclate immediate release (IR) tablets (75 mg and 150 mg) in the United States. Mayne Pharma has immediately commenced commercial launch to customers in the US.

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 US were approximately US$250 million for the twelve months ended April 2017.

Mayne Pharma's CEO, Mr Scott Richards, said "We are very pleased to have launched the first generic alternative to Acticlate in the US, providing 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 last year after dofetilide capsules, butalbital acetaminophen tablets (50 mg/300 mg) and methylphenidate extended-release capsules f60 mg).

Mayne Pharma markets more than 50 products and has a growing pipeline of more than 40 products targeting US markets with I MS sales greater than US$7 billion. With 18 drug applications pending at the FDA, Mayne Pharma anticipates additional product launches within the coming year.

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Publication:Mena Report
Date:Jun 17, 2017
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