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Aurobindo receives FDA approval for hypertension, antibiotic drugs

BY Alaric DeArment

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer’s Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

Last week, the drug maker received approval for cefadroxil for oral suspension in the 250 mg-per-5 mL and 500 mg-per-5 mL strengths. The drug is a generic version of Warner Chilcott’s Duricef and is a cephalosporin antibiotic for treating certain bacterial infections, including urinary tract infections caused by E. coli, P. mirabilis and Klebsiella bacteria; skin and skin-structure infections caused by staphylococci and streptococci; and pharyngitis and tonsillitis caused by Streptococcus progenies. Various versions of the drug had sales of about $6 million during the 12-month period that ended in September, according to IMS.

 

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L.A. Looks kicks off model search on Facebook

BY Antoinette Alexander

STAMFORD, Conn. — Hair styling brand L.A. Looks, which is owned by Newhall Labs, has kicked off a model search on Facebook.

Through the contest, women and men ages 18 years and older can submit a photo for a chance to win a trip to Los Angeles for a professional photo shoot, and potential exposure in an upcoming L.A. Looks marketing campaign.

“L.A. Looks has incredibly dedicated fans with a great sense of style, so it was just natural to look among them as we search for our next models,” stated Jon Achenbaum, Newhall Labs’ CEO.  “This is going to be an exciting year for L.A. Looks fans, with new products on tap, exciting promotions and refreshed websites and social channels.”


Fans can visit the L.A. Looks Facebook page and enter by submitting a photo through July 31.  Entries will be judged on originality, creativity, quality of photo and overall appeal. Up to 10 girls and 10 guys will be chosen as finalists and showcased on the L.A. Looks Facebook page from August 8 to 21, where fans can vote for winners. Two grand-prize winners, who will receive a trip to Los Angeles that includes transportation, hotel, meals and participation in a professional photo shoot, will be announced on or around August 26.

In addition to its home on Facebook, the contest will be promoted on-pack, in FSI’s in Sunday newspapers on May 12 and July 28, as well as online at LALooks.com.
 

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FDA approves anticoagulant-reversal product

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

The FDA announced the approval of CSL Behring’s Kcentra (prothrombin complex concentrate [human]) for the urgent reversal of vitamin K antagonist, or VKA drugs such as warfarin.

Previously, the only treatment available for this use was plasma, according to the agency, but plasma must be frozen and requires thawing and blood group typing before use, while Kcentra does not, thus allowing for faster administration.

"The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," FDA Center for Biologics Evaluation and Research director Karen Midthun said. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."


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