Biaxin_XL: profile and news

UPDATE 2-Andrx shares drop on generic Biaxin ruling  Nov 11, 2005
...(ABT.N: Quote, Profile, Research) said a court granted a preliminary injunction related to Andrx's generic version of the antibiotic Biaxin XL. ... - Reuters

Abbott Labs Still Has 'Considerable' Upside Potential  Nov 28, 2005
Positive events for Abbott in 2005 included defending the Biaxin XL franchise against generic competition, gaining access to rapid exchange stent delivery ... - Forbes

Andrx comments on court decision  Nov 11, 2005
...the course of action it will take following the preliminary injunction handed down against its generic version of Abbott Laboratories Inc.'s Biaxin XL Filmtab. ... - BusinessWeek

US District Court Grants Abbott's Request for a Preliminary ...  Nov 11, 2005
Court in Chicago today granted Abbott's request for a preliminary injunction that will prevent unauthorized generic copies of Abbott's Biaxin XL from Ranbaxy ... - PR Newswire (press release),

Andrx Corporation Reports 2005 Third Quarter Results  Nov 8, 2005
...goods sold of $4.1 million in write-offs of pre-launch inventories, mainly due to $3.4 million in write-offs of our generic version of Biaxin XL in connection ... - PharmaLive.com (press release),

Abbott says court grants injunction in Biaxin case  Nov 10, 2005
...said on Thursday the US District Court in Chicago granted the company's request for a preliminary injunction involving its antibiotic Biaxin XL. ... - Reuters India,

Abbott wins new round of approval for Humira  Oct 5, 2005
...this summer that was below analysts' expectations, FDA rejection of its prostate cancer drug Xinlay and potential generic risk facing its antibiotic Biaxin XL. ... - Chicago Sun-Times,

Abbott Shares At 'Compelling Entry Point'  Sep 20, 2005
...third quarter, possibly on investor concerns for last week's Food and Drug Administration Xinlay panel rejection and the threat of Biaxin XL generics," Bear ... - Forbes

Andrx "neutral"  Sep 1, 2005
...note published this morning, the analyst mentions that the company's share price declined recently due to the approval of Sandoz's generic Biaxin XL drug. ... - New Ratings

Abbott Labs' Products Could See Sales Upside  Aug 17, 2005
Near-term potential catalysts include the Andrx (nasdaq: ADRX - news - people ) hearing over Biaxin XL in early September and the ODAC panel on Xinlay.". ... - Forbes

Teva Shares Could Rise 15%-20% In 12 Months  Aug 2, 2005
...second-quarter results--which was not overly surprising given the near-term challenges and pre-announcement surrounding the generic Biaxin XL delay," said SG ... - Forbes

Andrx Corporation Reports 2005 Second Quarter Results  Jul 28, 2005
...entered into an agreed temporary restraining order (TRO) to enjoin us from selling or offering to sell our generic version of Biaxin XL in the United States ... - Business Wire (press release)

Andrx logs Q2 profit rise  Jul 29, 2005
..."We continue to expect to launch our generic versions of Biaxin XL and other products, including additional generic oral contraceptives later this year, as ... - South Florida Business Journal

William Blair: Investor fears create "compelling opportunity" in ...  Jul 14, 2005
...a District Court judge granted Abbott Laboratories (ABT $49.99) a preliminary injunction preventing Teva from launching Biaxin XL (clarythromycin extended ... - Globes Online <**results**>

UBS sees 20% revenue growth for Teva next year  Jun 28, 2005
...in total. The company also received approval for generic Biaxin XL on May 18, but the patent does not expire until May 23. Teva ... - Globes Online,

Teva Shareholders Feeling Ill  Jun 6, 2005
Abbott Laboratories (ABT:NYSE - commentary - research) has said Teva's clarithromycin extended release tablets infringe on its patent for Biaxin XL Filmtabs. ... - TheStreet.com

"Bad News" for Teva? Yawn...  Jun 6, 2005
Why? Because a judge issued a preliminary injunction forbidding Teva from selling a generic form of Abbott Labs' (NYSE: ABT) Biaxin XL (clarithromycin extended ... - Motley Fool

Abbott Laboratories "top pick"  Jun 6, 2005
...a research note published this morning, the analyst mentions that a federal judge has granted preliminary injunction against Teva's generic version of Biaxin XL ... - New Ratings

Teva Shares Slump 8% After Company Cuts Profit Target (Update2)  Jun 5, 2005
The court on June 3 granted Abbott's request to bar Teva from selling a generic of the slow-release version of Biaxin XL Filmtabs until a patent infringement ... - Bloomberg

Teva falls on news of drug delay  Jun 6, 2005
Abbott Laboratories' (ABT: news, chart, profile) request for a preliminary injunction against the launch of a generic version of Abbott's Biaxin XL Filmtabs. ... - MarketWatch

Teva drops 8% on forecast cut  Jun 5, 2005
...concerning the product. The medication is a generic equivalent of Abbott's antibiotic Biaxin XL Filmtabs. "Investors were surprised ... - Jerusalem Post,

Abbott Laboratories "buy"  Jun 6, 2005
...morning, the analysts mention that a US district court has given a preliminary injunction against the generic version of Abbott Laboratories' Biaxin XL drug by ... - New Ratings

Teva falls on news of drug delay  Jun 6, 2005
...in Illinois had granted Abbott Laboratories' (ABT) request for a preliminary injunction against the launch of a generic version of Abbott's Biaxin XL Filmtabs. ... - Investor's Business Daily (subscription)

Teva Pharmaceutical "buy," estimates reduced  Jun 7, 2005
...years, the analyst says. The company is unlikely to launch the generic version of Biaxin XL in 2005, Deutsche Bank Securities adds. - New Ratings

Abbott Reports 16.0 Percent Sales Increase in the First Quarter  Apr 12, 2005
Q2) What are the details regarding new intellectual property for Biaxin XL and what is the outlook for Biaxin sales in 2005? A2) The ... - PR Newswire

Abbott Shares Rise on New Biaxin Patent  Mar 29, 2005
...on Tuesday said it received a new patent for Biaxin XL, the extended-release form of the antibiotic clarithromycin, blocking a handful of rivals from launching ... - Forbes

Abbott "buy"  Mar 29, 2005
...note published yesterday, the analyst mentions that the company is expected to receive additional IP to identify the uniqueness of its Biaxin XL product. ... - New Ratings

Zacks Brokerage Buy List: Abbot Labs, Automatic Data Processing ...  Apr 1, 2005
Earlier this week, the company said that the US Patent and Trademark Office issued a new patent for BIAXIN XL, which delays rivals from developing a generic ... - Business Wire

S&P Keeps Buy on AIG  Apr 12, 2005
Assumptions include successful defense of Biaxin XL from generics. Our 12-month discounted-cash-flow-based target price remains $54. ... - BusinessWeek

Business Briefs  Mar 30, 2005
Holdings Inc. Abbott Laboratories received new patent protection for its antibiotic Biaxin XL, which has faced generic challenges. The ... - Chicago Sun-Times

Safety Issues Dominate Health News  Apr 2, 2005
...nyse: ABT - news - people ) rose this week after the biotech firm said on Tuesday that it received new patent protection for its antibiotic Biaxin XL. ... - Forbes

Hot Stocks: PRV THC LPNT CYH UHS TRI HMA -3-  Mar 29, 2005
ABBOTT LABORATORIES (ABT) Said Tuesday that the US Patent and Trademark Office issued a new patent for Biaxin XL, the extended release form of the antibiotic ... - Yahoo News

First-Time Generic Approvals: Terazol 7, DDAVP Nasal Spray, Biaxin ...  Feb 18, 2005
The 1-g generic formulation is considered to be equivalent to two 500-mg tablets of the brand-name formulation (Biaxin XL Filmtab, made by Abbott Laboratories ... - Medscape (subscription)

Abbot Labs "buy"  Feb 16, 2005
...published this morning, the analyst mentions that the market believes that the company would lose the composition of matter patent for its Biaxin XL drug in ... - New Ratings

Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline or with baseline concentrations in the upper therapeutic range. In two studies in which theophylline was administered with clarithromycin (a theophylline sustained-release formulation was dosed at either 6.5 mg/kg or 12 mg/kg together with 250 or 500 mg q12h clarithromycin), the steady-state levels of C_max, C_min, and the area under the serum concentration time curve (AUC) of theophylline increased about 20%.

Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine. Blood level monitoring of carbamazepine may be considered.

When clarithromycin and terfenadine were coadministered, plasma concentrations of the active acid metabolite of terfenadine were threefold higher, on average, than the values observed when terfenadine was administered alone. The pharmacokinetics of clarithromycin and the 14-hydroxy-clarithromycin were not significantly affected by coadministration of terfenadine once clarithromycin reached steady-state conditions. Concomitant administration of clarithromycin with terfenadine is contraindicated.

Clarithromycin 500 mg every 8 hours was given in combination with omeprazole 40 mg daily to healthy adult subjects. The steady-state plasma concentrations of omeprazole were increased (C_max, AUC_0-24, and T_½ increases of 30%, 89%, and 34%, respectively), by the concomitant administration of clarithromycin. The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when co-administered with clarithromycin.

Co-administration of clarithromycin with ranitidine bismuth citrate resulted in increased plasma ranitidine concentrations (57%), increased plasma bismuth trough concentrations (48%), and increased 14-hydroxy-clarithromycin plasma concentrations (31%). These effects are clinically insignificant.

Simultaneous oral administration of clarithromycin and zidovudine to HIV-infected adult patients resulted in decreased steady-state zidovudine concentrations. When 500 mg of clarithromycin were administered twice daily, steady-state zidovudine AUC was reduced by a mean of 12% (n=4). Individual values ranged from a decrease of 34% to an increase of 14%. Based on limited data in 24 patients, when clarithromycin was administered two to four hours prior to oral zidovudine, the steady-state zidovudine C_max was increased by approximately 2-fold, whereas the AUC was unaffected.

Simultaneous administration of clarithromycin and didanosine to 12 HIV-infected adult patients resulted in no statistically significant change in didanosine pharmacokinetics.

Concomitant administration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily to 21 healthy volunteers led to increases in the mean steady-state clarithromycin C_min and AUC of 33% and 18%, respectively. Steady-state concentrations of 14-OH clarithromycin were not significantly affected by concomitant administration of fluconazole.

Concomitant administration of clarithromycin and ritonavir (n=22) resulted in a 77% increase in clarithromycin AUC and a 100% decrease in the AUC of 14-OH clarithromycin. Clarithromycin may be administered without dosage adjustment to patients with normal renal function taking ritonavir. However, for patients with renal impairment, the following dosage adjustments should be considered. For patients with CL_CR 30 to 60 mg/min, the dose of clarithromycin should be reduced by 50%. For patients with CL_CR < 30 ml/min, the dose of clarithromycin should be decreased by 75%.

Spontaneous reports in the post-marketing period suggest that concomitant administration of clarithromycin and oral anticoagulants may potentiate the effects of the oral anticoagulants. Prothrombin times should be carefully monitored while patients are receiving clarithromycin and oral anticoagulants simultaneously.

Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in post-marketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin levels should be carefully monitored while patients are receiving digoxin and clarithromycin simultaneously.

The following drug interactions, other than increased serum concentrations of carbamazepine and active acid metabolite of terfenadine, have not been reported in clinical trials with clarithromycin; however, they have been observed with erythromycin products and/or with clarithromycin in post-marketing experience.

Concurrent use of erythromycin or clarithromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.

Erythromycin has been reported to decrease the clearance of triazolam and, thus, may increase the pharmacologic effect of triazolam. There have been post-marketing reports of drug interactions and CNS effects (e.g., somnolence and confusion) with the concomitant use of clarithromycin and triazolam.

There have been reports of an interaction between erythromycin and astemizole resulting in QT prolongation and torsades de pointes. Concomitant administration of erythromycin and astemizole is contraindicated. Because clarithromycin is also metabolized by cytochrome P450, concomitant administration of clarithromycin with astemizole is not recommended.

As with other macrolides, clarithromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin), through inhibition of cytochrome P450 metabolism of these drugs. Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.

The use of erythromycin and clarithromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of erythromycin and/or clarithromycin with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfentanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide, rifabutin, and astemizole. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving these drugs.