FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Approves Redesigned Gonal-f Redi-ject Pen

[ Price : $8.95]

FDA approves an EMD Serono supplemental NDA for a redesigned version of Gonal-f RFF Redi-ject (follitropin alfa injection) pen inj...

Expanded Use for Vraylar in Schizophrenia Approved

[ Price : $8.95]

FDA approves an Allergan supplemental NDA for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia.

NDA Accepted for Sunovian ADHD Drug

[ Price : $8.95]

FDA accepts for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake in...

FDA Approves Dynavax BLA for Hepatitis B Vaccine

[ Price : $8.95]

FDA approves a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against he...

Lensar Astigmatism Management Feature Cleared

[ Price : $8.95]

FDA clears a Lensar 510(k) for its IntelliAxis-L, the companys latest astigmatism management feature to guide toric intraocular le...

FDA Clears Neusoft Medical New CT Scanner

[ Price : $8.95]

FDA clears a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner.

Heron NDA for Nausea Drug Approved

[ Price : $8.95]

FDA approves a Heron Therapeutics NDA for Cinvanti (aprepitant) injectable emulsion, a P/neurokinin-1 receptor antagonist indicate...

FDA Harmonizing MDR Adverse Event Coding with Other Regulators

[ Price : $8.95]

As part of an adverse event harmonization effort, FDA says it is no longer adding new adverse event codes for Medical Device Repor...

Teligent ANDA for Betamethasone Dipropionate Approved

[ Price : $8.95]

FDA has approved a Teligent ANDA for a generic copy of Promius Pharmas Sernivo, indicated for treating mild-to-moderate plaque pso...

FDA Hits Lupin with Warning on 2 Indian Facilities

[ Price : $8.95]

FDA issues a combined Warning Letter to India-based Lupin after two drug manufacturing facilities at Goa and Indore were inspected...