This product is the therapeutic equivalent to the reference listed drug, Paxil CR
Extended-Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg, of Apotex Technologies, the company said.
The defective drugs, manufactured between 2001 and 2005, were Kytril, Bactroban, Paxil CR
, and Avandamet.
Lilly's fluoxetine (Prozac) was approved under the trade name Sarafem for premenstrual dysphoric disorder in 2000, Pfizer's sertraline (Zoloft) added the PMDD claim in 2001, and GlaxoSmithKline's paroxetine (Paxil CR
) followed in 2003.
Brands/options Citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Prozac Weekly), paroxetine (Paxil, Paxil CR
), sertraline (Zoloft).
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, 12.5 mg, 25 mg and 37.5 mg.
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.
The AP wire story also disclosed that GlaxoSmithKline PLC had produced tablets of the popular antidepressant Paxil CR
that split apart, potentially causing patients to take an incorrect dosage.
The patients were randomized to treatment with either paroxetine-CR (Paxil CR
) 12.5 mg daily or placebo for 12 weeks.
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after it was withdrawn amid fears over its quality - but analyst Jeremy Batstone at stockbroker Charles Stanley said its return came too late to affect Thursday's interim results.