PHARMACY

FDA approves Lopid generic from Aurobindo

BY DSN STAFF

Dayton, N.J. — Aurobindo Pharma Limited announced Monday that it had received approval from the Food and Drug Administration for its generic of Pfizer’s Lopod (gemfibrozil) tablets in 600-mg dosage strength.

The drug is intended to treat high cholesterol alongside diet and exercise. Brand sales for Lopid in the U.S. were about $35.1 million for the twelve months ended July 2015, according to IMS Health. 

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Sprout announces availability of Addyi REMS training

BY David Salazar

RALEIGH, N.C. — Sprout Pharmaceuticals recently announced that pharmacists and providers can now enroll Risk Evaluaiton and Mitigation Strategy training to become certified to prescribe or dispense Addyi (filbanserin), the recently approved drug that treats hypoactive sexual desire disorder in premenopausal women. 
 
“We are committed to patient safety first and foremost, and as such, our priority is to educate prescribers and pharmacies about Addyi leading up to its availability,” Sprout CEO Cindy Whitehead said. “The millions of women who suffer from HSDD have been awaiting a treatment option for years, and we look forward to working with healthcare providers and pharmacies to provide them with education on Addyi.”
 
The REMS materials can be accessed from Addyi.com and prescriber and pharmacists have to review and complete a knowledge assessment. The program is designed to reduce the risk of syncope and hypertension that can occur when Addyi interacts with alcohol. 
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Endo completes acquisition of Par Pharmaceutical

BY David Salazar

DUBLIN — Endo International has completed its more than $8 billion acquisition of Par Pharmaceuticals, the company announced Monday. As a result of the cash-and-stock acquisition — which Endo said adds a quickly growing generics portfolio to its specialty offerings — the company has updated its financial guidance for the year.

"The acquisition of Par has transformed our business, expanding Endo's overall corporate profile, scope and size and establishing a powerful platform for future M&A,” Endo CEO and president Rajiv De Silva said. “With the Par addition to our already-growing base business, we believe we are positioned to deliver strong financial results through the remainder of 2015.” 

Now the company expects total revenue between $720 million and $740 million, for the third quarter and projected yearly revenue of $3.22 billion and $3.27 billion.

“We believe Par will further position us to deliver strong financial results in 2016, based on projected double-digit underlying revenue growth, strong and rapid synergy capture and additional benefits from our tax strategy,” De Silva said. 

Par will now be known as Par Pharmaceutical, an Endo International Company and will be headed by former Par CEO Paul Campanelli, who will assume the role of group president for the company. 

“I am excited to be joining Endo along with key members of the Par team,” Campanelli said. “We look forward to helping realize the full potential of this new — and highly specialized — generics business.”

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