This product is the therapeutic equivalent to the reference listed drug, Paxil CR
Extended-Release Tablets USP, 12.
Ortiz said the company allowed several drugs to be adulterated between 2001 and 2005, including Paxil CR
, a skin-infection ointment called Bactroban, an anti-nausea drug called Kytril, and a diabetes drug called Avandamet.
22 September 2010 - US Mylan Inc (NASDAQ: MYL) said yesterday it has received a temporary restraining order from the US District Court for the District of New Jersey that prohibits Apotex from selling and/or importing all three strengths of a generic version of GlaxoSmithKline's (LON: GSK) Paxil CR
, Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, 12.
Cheap copies of the antidepressant Paxil CR
and another four products cut pounds 450m from Glaxo's first-quarter sales, the company said last month.
Cheaper copies of the antidepressant Paxil CR
and another four products trimmed 450 million pounds from sales compared with the same quarter a year earlier, Witty said.
GlaxoSmithKline, which markets Paxil CR
, supplied the drug used in this study, but otherwise the study and investigators received no industry support.
Dr Senior said other issues were more worrying, including the decision by GlaxoSmithKline not to defend patents covering its anti- depressant Paxil CR
, making generic competition more likely in the second half of next year.
The firm recently reintroduced anti-depressant Paxil CR
after it was withdrawn amid fears over its quality - but analyst Jeremy Batstone at stockbroker Charles Stanley said its return came too late to affect Thursday's interim results.
The company's stock fell sharply in March when the Food and Drug Administration (FDA) forced it to withdraw antidepressant Paxil CR
and its Avandamet diabetes treatment amid concerns they were of poor quality.
SkyePharma has a partnership with GlaxoSmithKline for marketing depression drug Paxil CR
and is developing new versions of drugs including AstraZeneca's Pulmicort and GlaxoSmithKline's Requip.
The drugs, manufactured in Puerto Rico between 2001 and 2005, included the antinausea drug Kytril, the antidepressant Paxil CR
, the diabetes medication Avandamet, and the anti-infection ointment Bactroban.
The procedures were implemented as part of a consent decree with the FDA that was signed last year by GSK after the company was cited for manufacturing deficiencies associated with Paxil CR
(paroxetine) and Avandamet (rosiglitazone and metformin), which are produced at the same Cidra, Puerto Rico, manufacturing facility that makes Coreg.