BioCentury | Feb 1, 2020
Company News

Any chance left for safer opioids?

...through the acquisition of four programs from Iroko Pharmaceuticals LLC. Anticipating a similar fate for Troxyca ER...
BioCentury | Oct 3, 2016
Finance

Dressed in black

...approves Erelzi etanercept-szzs, a biosimilar of autoimmune disease drug Enbrel Pfizer Inc. (NYSE:PFE) FDA approves Troxyca ER...
BioCentury | Sep 5, 2016
Clinical News

Troxyca ER oxycodone/naltrexone regulatory update

...FDA approved an NDA from Pfizer for Troxyca ER oxycodone/naltrexone to manage pain severe enough to require...
...The pharma plans to launch Troxyca ER in 1Q17 and is still determining the drug’s price. Troxyca ER...
...features described in its label. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Troxyca ER oxycodone/naltrexone ( ALO-02...
BioCentury | Aug 22, 2016
Company News

FDA approves Pfizer's Troxyca ER

...FDA approved Troxyca ER oxycodone/ naltrexone from Pfizer Inc. (NYSE:PFE) to treat pain severe enough to require...
...it as abuse deterrent via the oral route (see BioCentury Extra, June 8, 2016) . Troxyca ER's...
...to determine whether the drug will reduce IV abuse compared with oxycodone alone. Pfizer said Troxyca ER...
BioCentury | Jun 13, 2016
Clinical News

Troxyca ER oxycodone/naltrexone regulatory update

...and Drug Safety and Risk Management advisory committees voted 9-6 to recommend approval of Pfizer’s Troxyca ER...
...IV route. They voted 9-6 against labeling it as abuse deterrent via the oral route. Troxyca ER...
...date (see BioCentury, March 21). Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Troxyca ER oxycodone/naltrexone ( ALO-02...
BioCentury | Jun 9, 2016
Company News

FDA panel backs Troxyca efficacy, two abuse claims

...and Risk Management advisory committees voted 9-6 to recommend approval of Troxyca ER oxycodone/ naltrexone ( ALO-02...
...IV administration. They voted 9-6 against labeling it as abuse deterrent via the oral route. Troxyca...
...oxycodone, an opioid agonist, surrounding sequestered naltrexone, an opioid receptor antagonist. Panel members found that Troxyca...
BioCentury | Jun 8, 2016
Company News

FDA panels recommend Teva's Vantrela ER

...tablet. On Wednesday, the panels are to discuss an NDA for Troxyca ER oxycodone/ naltrexone ( ALO-02...
BioCentury | Mar 21, 2016
Clinical News

Oxycodone/naltrexone regulatory update

...Management advisory committees will meet on June 8 to discuss an NDA from Pfizer for ALO-02...
...additional data analyses or data requests. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Oxycodone/naltrexone ( ALO-02...
BioCentury | Mar 17, 2016
Politics & Policy

FDA panels to discuss two more pain products

...meet in June to discuss pain candidates CEP-33237 from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and ALO-02...
...formulated with an abuse-deterrent technology. On June 8, the panels will discuss an NDA for ALO-02...
BioCentury | Feb 1, 2016
Politics, Policy & Law

Opioids clouding Califf's tenure

...science and another on politics. At least five opioids are under review at FDA, including ALO-02...
..."Political Pain"). Pfizer announced on Oct. 27 that FDA had extended the PDUFA goal for ALO-02...
..."Pain politics." BioCentury (2014) Tables Political pain Company Product Description Indication Status Pfizer Inc. (NYSE:PFE) ALO-02...
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