FDA grants tentative approval to Aurobindo HIV drug
HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.
Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences’ Atripla.
Tentative approval means that the drug meets the FDA’s requirements for approval, but the agency can’t give it final approval because the branded drug’s patent protection hasn’t expired. The tentative approval was given under the President’s Emergency Plan for AIDS Relief, or PEPFAR, which aims to provide low-cost HIV medications to people in poor countries.
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URAC gives accreditation to PBM-owned specialty pharmacy
LISLE, Ill. — Washington-based accrediting organization URAC has accredited pharmacy benefit manager Catamaran Corp.’s specialty pharmacy brand, Catamaran said.
The PBM said BriovaRx had been awarded URAC’s Specialty Pharmacy Accreditation. Catamaran said URAC offered the only third-party, voluntary accreditation program of this scope for the pharmacy benefit management and prescription services industry.
"BriovaRx’s robust offerings focus on the patient, ensuring one-on-one support and a personalized plan that addresses chronic conditions to help them lead healthy, vibrant lives," Catamaran chairman and CEO Mark Thierer said. "The URAC accreditation is a reflection of BriovaRx’s patient-centric approach that coordinates the efforts of providers, payers and manufacturers to keep treatments personalized and successful."
URAC president and CEO Alan Spielman said BriovaRx’s application for and receiving of accreditation demonstrated "a commitment to quality health care."
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Dr. Reddy’s launches generic osteoporosis drug
HYDERABAD, India — Dr. Reddy’s Labs has launched zoledronic acid injection in the 5 mg-per-100-mL strength, the Indian generic drug maker Thursday.
The drug, launched following its approval by the Food and Drug Administration, is a generic version of Novartis’ Reclast and is used to treat osteoporosis. Reclast had sales of $355 million during the 12-month period that ended in February, according to IMS Health.
The launch follows last month’s launch of zoledronic acid injection in the 4-mg-per-5-mL, a generic version of Novartis’ Zometa, which is another version of the drug used to treat the cancer multiple myeloma and cancers that have spread to the bones.
CORRECTION: An earlier version of this story misstated the strength of Dr. Reddy’s generic version of Zometa. The story has been corrected.