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FDA Determines Regulatory Review Period for Baxters Obizur

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Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,21...

Draft Guide for Methylphenidate Hydrochloride ANDAs

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Federal Register notice: FDA makes available a new draft guidance for industry on generic methylphenidate hydrochloride oral exten...

Regulatory Review Period for Inspire Sleep Apnea Device

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FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,216 days.

FDA Approves Janssens Simponi Aria for 2 New Indications

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FDA approves Janssen Biotechs Simponi Aria (golimumab) for treating adults with active psoriatic arthritis and active ankylosing s...

FDA Approves Glaxos Shingrix Shingles Vaccine

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FDA approves a GlaxoSmithKline BLA for its Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoste...

2 Octagam Lots Withdrawn from Market

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Octapharma USA withdraws two lots of Octagam 10% [immune globulin intravenous (human)] liquid preparation] that is labeled with lo...

FDA Warning Letter to Magellan Diagnostics

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FDA issues a Warning Letter to Magellan Diagnostics for modifying versions of two of its blood lead testing systems without the ag...

SCA Pharma Recalls Injectables Due to Contamination Concern

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SCA Pharmaceuticals recalls all lots of several injectable products because there is a potential for them to contain microbial con...

FDA Approves AstraZeneca NDA for Bydureon BCise

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FDA approves an AstraZeneca NDA for Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation designed ...

AstraZenecas Elavil Not Withdrawn Due to Safety/Effectiveness

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Federal Register notice: FDA determines that AstraZenecas Elavil (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, ...