Allergan, Endo, and Mayne Pharma Lead Drug ApprovalsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Allergan, Endo, and Mayne Pharma.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday October 26, 2016 date to Tuesday November 1, 2016.
Allergan Gets FDA OK for Multi-Dose Eye-Drug Delivery System
Allergan has received approval from the US Food and Drug Administration for Restasis Multidose (cyclosporine ophthalmic emulsion) 0.05%, a multi-dose bottle offering of the Restasis drug launched in 2003 for treating patients with a type of chronic dry eye.
Restasis is designed to help increase the eyes’ natural ability to produce tears, which may be reduced by inflammation due to chronic dry eye, according to Allergan. The multi-dose drug delivery system is designed with a unidirectional valve and air filter technology and uses less plastic than a package of single-use vials.
Endo Ships Generic Version of AstraZeneca’s Anti-Depressant Drug
Endo International, through its operating company, Par Pharmaceutical, has begun shipping four dosage strengths (50 mg, 150 mg, 200 mg and 300 mg) of quetiapine fumarate extended-release tablets, the generic version of AstraZeneca’s Seroquel XR (quetiapine fumarate), an atypical antipsychotic indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder (as an adjunctive therapy with anti-depressants). As marketer and distributor of the generic product, Par will have 180 days of marketing exclusivity for these four strengths and will share profits with its partners, Handa Pharmaceuticals and Deerfield Generics, a portfolio company of Deerfield Management Company.
AstraZeneca reported 2015 sales of $1.025 billion for Seroquel XR. According to IMS Health data and as cited by Endo, US sales of Seroquel XR for the four dosage strengths to be marketed by Par are approximately $911 million for the 12 months ended September 30, 2016.
Source: Endo Pharmaceuticals
Mayne Pharma Launches Generic Version of Crohn’s Disease Drug
Mayne Pharma, an Adelaide, Australia-headquartered specialty pharmaceutical company, has launched a generic version of Perrigo’s Entocort EC (budesonide capsules) 3mg in the US, a treatment for mild-to-moderate Crohn’s disease. US brand and generic sales of budesonide capsules were approximately $322 million for the 12 months ending 31 August 2016, according to IMS Health and as cited by Mayne Pharma.
Mayne Pharma acquired the generic budesonide capsules in August 2016 as part of its $652-million acquisition of 37 approved and five filed generic pharmaceutical products from Teva Pharmaceutical Industries, following Teva’s closing of its $40.5-billion acquisition of the generics business of Allergan, also in August 2016. The generic budesonide capsules will be manufactured at Mayne Pharma’s facility in Salisbury, South Australia.
Entocort EC was acquired by Perrigo in December 2015 in a $380-million deal with AstraZeneca. The deal granted Perrigo the rights to sell Entocort capsules and the authorized generic Entocort capsules marketed by Par Pharmaceuticals.
Source: Mayne Pharma