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- PMLiVE

paediatrics

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FDA says approval of generic Doxil will ease cancer drug shortage

Allows Sun Pharma to manufacture its own version of the medicine

FDA clears Hyperion’s Ravicti for urea cycle disorders

Plans to launch in US by end of April

- PMLiVE

FDA advisors back Boehringer’s COPD drug olodaterol

Committee votes 15 to 1 in favour despite cancer concerns

Sanofi reception

US approval for Sanofi’s Kynamro in genetic cholesterol disorder

Comes one month after drug was turned down in Europe due to safety concerns

- PMLiVE

Takeda gets FDA approval for alogliptin franchise in diabetes

Comprises Nesina, Oseni and Kazano

- PMLiVE

Roche’s Avastin gains new US colon cancer approval

Patients can continue to use drug once disease progresses

- PMLiVE

Allergan gets US approval for Botox in overactive bladder

Could add $200m to annual sales

- PMLiVE

FDA approves first egg-free flu vaccine Flublok

Insect virus production method means more vaccine can be produced at a faster rate

- PMLiVE

FDA fast tracks two new lung cancer drugs

Boehringer’s afatinib and Roche/Astellas’ Tarveca receive accelerated review process

- PMLiVE

J&J gets FDA panel backing for canagliflozin

Moves ahead of BMS/AZ’s Forxiga in race for US approval as first in new class of diabetes drug

- PMLiVE

FDA lowers recommended dose for sleeping pills

Says insomnia drugs like Ambien could impair ability to drive in morning

- PMLiVE

FDA releases guidance on how to prevent abuse of opioid painkillers

Explains to companies best ways to make tamper-resistant drugs

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