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Alexza Submits Staccato NDA

[ Price : $8.95]

Alexza Pharmaceuticals submits an NDA to FDA for its Staccato loxapine inhalation drug for treating agitation in patients with sch...

FDA Updates 2 Drug Shortages, 1 Deletion

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FDA updates drug shortage and discontinuation information for methotrexate injection, mitomycin for injection and Vesanoid respect...

FDA Fast Track for Breast Cancer Therapy

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FDA grants BiPar Sciences fast track status for BSI-201 for treating metastatic triple-negative breast cancer.

FDA OKs Lannett ANDA for Generic Dilaudid

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FDA approves a Lannett ANDA for a generic copy of Purdue Pharmaceuticals' Dilaudid tablets.

Advisors Asked About Crestor Safety Concerns

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FDA asks the Endocrinologic & Metabolic Drugs Advisory Committee to comment on safety concerns from a trial of AstaZenecas Crestor...

Rx Drug Import Amendment Stalls Senate Reform Bill

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Senators stake out opposing positions on drug importation and threaten to block consideration of overall healthcare reform legisla...

Change of Animal Drug Sponsor to Janssen

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Federal Register Final rule: FDA amends its animal drug regulations to reflect a NADA sponsor change to Janssen Pharmaceutica.

Comments Extended on Combo Product Safety Reporting

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Federal Register Proposed rule: FDA extends the comment period for a proposed rule requesting comments on postmarketing safety rep...

Mylan ANDA for Generic Keppra 1,000 mg Approved

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FDA approves a Mylan ANDA for levetiracetam tablets 1,000 mg, a generic copy of UCB Pharmas antiepileptic Keppra.

CGMPs Guidance on PET Drugs

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Federal Register Notice: FDA releases a guidance, PET Drugs Current Good Manufacturing Practice.