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Aurobindo Recalls Ranitidine Products

[ Price : $8.95]

FDA says Aurobindo has recalled 38 lots of ranitidine products for unacceptable NDMA levels.

FDA Approves Celgenes Reblozyl for Some Anemic Adults

[ Price : $8.95]

FDA approves Celgenes Reblozyl as the first treatment for adults with anemia who have beta thalassemia and require regular red blo...

Cassiopea NDA Filed for New Acne Cream

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FDA accepts for review a Cassiopea NDA for clascoterone cream 1% for treating acne.

E-cigarette Rule Coming: Trump

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President Trump says new e-cigarette rules will be out within a week, including raising the purchasing age from 18 to 21.

Teleflex Class 1 Recall of Ventilator Manifold

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Teleflex begins a Class 1 recall of its Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is used with its ventilators, becaus...

Life Spine, 2 Execs, Settle Kickback Case

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Life Spine and two of its executives agree to pay nearly $6 million to resolve kickback allegations in a whistleblower suit.

Changes in Special 510(k) Guidance

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CDRH regulatory advisor Joshua Silverstein tells a Webinar what changes were made to the final Special 510(k) guidance in response...

AbbVie sNDA for Imbruvica/Rituximab Combo

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AbbVie files a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of younger pa...

FDA Withdraws Haemonetics ANDA

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Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plasti...

Info Collection on Generic Drug Correspondence

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Federal Register notice: FDA submits to OMB an information collection revision entitled for Controlled Correspondence Related to G...