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Sun Pharma’s Caraco gets FDA OK to resume operations

BY Allison Cerra

MUMBAI, India — The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco’s parent company Sun Pharmaceutical Industries said.

During their inspection, the FDA reviewed the certification reports for heart failure treatment Carvedilol USP, as well as antibiotic Paramomycin USP, and determined Caraco may resume production of only these two drugs.

"Manufacturing of other products from these sites, including those pending approval with [the FDA], will be subject to similar rigorous approval procedure," Sun Pharma said. "As a result, the increase in production at these sites and resultant revenue contribution is expected to be gradual."


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FDA approves new combination pill for HIV treatment for some patients

BY Allison Cerra

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

Gilead Sciences received regulatory for its treatment, Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate). Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate — approved in 2004 and marketed as Truvada — blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection.

"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens," said Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. "New combination HIV drugs like Stribild help simplify treatment regimens."


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NCPA endorses Pennsylvania pharmacy audit reform bill

BY Allison Cerra

ALEXANDRIA, Va. — The National Community Pharmacists Association is encouraging Pennsylvania lawmakers to favorably move legislation (known as H.B.727) that is designed to "establish minimum and uniform standards and criteria for the audit of pharmacy records."

"This important legislation is based on a simple principle: When a pharmacist dispenses the right medication to the right patient at the right time, as prescribed by a doctor, it should not be a punishable offense," NCPA CEO Douglas Hoey said. "Pharmacists recognize the need for legitimate audits to protect public and private health plans from waste, fraud and abuse. However, pharmacy auditing practices are out of control. Time-consuming, abusive audits compromise pharmacists’ availability to counsel patients. Increasingly, they appear to be more about generating revenue for the middleman than rooting out fraud."

NCPA noted that more than 20 states have enacted similar bills into law and 10 of those states — Alabama, Indiana, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, South Carolina, Utah and Vermont — have enacted or strengthened such laws in just the past five months. In California, such a measure recently passed both chambers of the state legislature.

Click here to read the letter.


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