Pharmacy News

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FDA News

5/16/12 - Acella Pharmaceuticals, LLC, Announces Approval of Generic Gabapentin Oral Solution

The Food and Drug Administration determined that Acella's ANDA is bioequivalent- therefore, therapeutically equivalent- to the reference listed drug, Neurontin Â®* Oral Solution, 250 mg/5 mL. "Acella looks forward to adding Gabapentin Oral Solution to our existing line of products, as we continue our product development strategy of gaining approva

5/16/12 - Boston Scientific announces FDA approval and launch of bradycardia device

May 16, 2012-- Boston Scientific Corporation, a developer of medical devices, has announced FDA approval and market launch of its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers, or CRT-P. The INGENIO, ADVANTIO and INVIVE devices are designed for use with Boston Scientific's new LATITUDE NXT Remote Patient...

5/16/12 - China : SFDA approves Baxter's Hemophilia Drug [TendersInfo (India)]

On Wednesday, Baxter International Inc. has announced that State Food and Drug Administration of China has granted approval to ADVATE for the control and prophylaxis of bleeding in individuals with hemophilia A. In China, around 50,000 people are expected to be living with hemophilia A. Ludwig Hantson, Ph.D., president of Baxter's BioScience busine

5/16/12 - FDA panel approves OraSure at-home HIV test [The Morning Call, Allentown, Pa.]

May 16-- An advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of OraSure Technologies Inc.' s at-home HIV test, setting it up to be the first of its kind in the country. OraQuick now will go before FDA regulators, who will make the final determination if the test kit, which would sell for less than $60, will be

5/16/12 - Napo Comments on FDA Announcing Extension of Crofelemer NDA Priority Review

The FDA apparently notified Salix that it extended the PDUFA date by three months because it needs additional time to conduct a full review of the NDA. According to Salix, the FDA has not requested additional studies. Although Salix filed the NDA with the FDA for CRO-HIV, Napo discovered and developed crofelemer and owns all the IP related to the d

5/16/12 - Truvada Receives FDA Approval

The approval was given by an advisory panel to the Food and Drug Administration in the United States this week after the majority of experts voted for licensing of the drug. "If taken it works," said Dr John Mellors, chief of the infectious diseases division at the University of Pittsburgh in USA.. However, some members expressed concern about pro

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