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FDA approves two new indications for Epaned

BY Ryan Chavis

DENVER — Silvergate Pharmaceuticals on Monday announced that the Food and Drug Administration approved Epaned (enalapril maleate Powder for oral solution) for the treatment of symptomatic heart failure, as well as the treatment of asymptomatic left ventricular dysfunction. The drug was previously approved to treat high blood pressure in patients older than one month of age. 
 
"Now with three indications, Epaned is available to help more patients who need the proven benefits of enalapril in an FDA-approved powder for oral solution, thereby ensuring that they are receiving a medicine that meets the highest quality standards," said Frank Segrave, president and CEO, Silvergate Pharmaceuticals.
 
 
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Court rules in favor of Mylan’s generic Precedex

BY Ryan Chavis

PITTSBURGH — Mylan is now free to resume distribution of its generic Precedex product (dexmedetomidine hydrochloride injection) to customers, effective immediately. 
 
The U.S. District Court for the District of Maryland granted summary judgment in favor of the company, Par Sterile Products, and the Food and Drug Administration. The court also lifted a temporary restraining order related to the generic. The drug received FDA approval in August. 
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L’Oréal to acquire Niely Cosmeticos in Brazil

BY Antoinette Alexander

PARIS — L'Oréal has signed an agreement to acquire Brazil’s Niely Cosmeticos, an independent hair coloration and hair care company.

Financial terms of the deal, which is subject to the usual regulatory approvals, were not disclosed.

Founded in 1981 by Daniel Fonseca de Jesus, Niely Cosmeticos generated net revenue of 405 million Brazilian Reals (140 million euros) in 2013.

Niely Cosmeticos group has two main brands: Cor & Ton for hair coloration and Niely Gold for shampoos and care. Niely Cosmeticos products are widely distributed throughout retailers and wholesalers, supermarkets, pharmacies and perfumery chains. Furthermore, Niely Cosmeticos has industrial and logistical facilities in Nova Iguaçu, in the State of Rio.

"The acquisition of Niely Cosmeticos is a strategic move for L'Oréal in Latin America and Brazil, one of the biggest and fastest-growing hair color and hair care markets in the world where consumers have a long tradition of beauty and demanding expectations" said Frédéric Rozé, EVP of L'Oréal in charge of the Americas.

Didier Tisserand, president of L'Oréal Brazil, added, "We are thrilled to welcome Niely to the L'Oréal group. Niely benefits from an excellent position and high penetration of the growing Brazilian middle class, and as such will positively complement the products offered by our Consumer Products Division in Brazil."

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