Par Pharmaceutical Begins Shipment Of Additional Dosage Strength Of Generic TOPROL-XL(R)

Main Category: Hypertension
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 04 Aug 2007 - 0:00 PDT

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Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced it had begun shipping metoprolol succinate extended release 50 mg tablets. As previously announced, in November 2006 Par entered into a supply and distribution agreement with AstraZeneca in the U.S. to distribute metoprolol succinate extended release tablets, which is substitutable for AstraZeneca's TOPROL-XL(R) extended release tablets. Par began shipping 25 mg tablets of generic Toprol-XL at that time.

TOPROL-XL is a beta-1-selective (cardioselective) adrenoceptor-blocking agent, for oral administration, available as extended release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration.

Annual U.S. sales of TOPROL-XL in the 50 mg tablet are approximately $640 million, according to IMS Health.

Important information about metoprolol succinate extended release tablets

Metoprolol succinate extended release is indicated for the treatment of hypertension, alone or in combination with other antihypertensives; the long- term treatment of angina pectoris; and the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis.

Metoprolol succinate extended release is contraindicated in severe bradycardia, heart block of greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.

In clinical trials of patients with hypertension and angina pectoris, the most common adverse events reported with immediate release metoprolol tartrate are tiredness (10%), dizziness (10%), depression (5%), diarrhea (5%), pruritus or rash (5%), shortness of breath (3%), and bradycardia (3%).

In patients with heart failure, serious adverse events and adverse events leading up to discontinuation of study medication in MERIT-HF at an incidence greater then or equal to 1% in the group receiving metoprolol succinate extended release and greater than placebo by more than 0.5% were dizziness/vertigo (1.8% vs. 1.0%), bradycardia (1.5% vs. 0.4%), and accident and or injury (1.4% vs. 0.8%).

Patients taking metoprolol succinate extended release should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, is some cases, myocardial infarction have occurred. The dosage should be reduced gradually over a one-to-two-week period, and the patient should be carefully monitored.

Metoprolol succinate extended release should be used with caution in patients who have bronchospastic disease, diabetes, thyrotoxicosis, or peripheral vascular disease; who are undergoing major surgery, or who take calcium channel blockers of the verapamil and diltiazem type.

There is a risk of worsening cardiac failure during up-titration of the dose of metoprolol succinate extended release. Patients need to consult their physicians if the experience signs or symptoms of worsening heart failure such as weight gain or increased shortness of breath.

Patients should be advised to (1) avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient's response to therapy with metoprolol succinate extended release has been determined; (2) contact a physician if any difficulty in breathing occurs; (3) inform the physician or dentist before any surgery that he or she is taking metoprolol succinate extended release.

About Par

Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit http://www.parpharm.com.

Safe Harbor Statement

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and as such, are subject to risks and uncertainties, including the extent and impact of litigation arising out of the accounting issue described in this and prior public announcements, including the lawsuit brought against the company by the trustee for the company's Senior Subordinated Convertible Notes seeking an accelerated payment of the $200 million of principal of and accrued interest on the notes or, in the alternative, damages, the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against the company, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission (SEC), such as the company's reports on Form 10-K, Form 10-Q, and Form 8-K, and amendments thereto. The company can make no assurance as to the potential effects of the restatement, including the effects of any investigations, informal or otherwise, conducted by the SEC, or other entities, or lawsuits filed against the company in connection therewith. Any forward-looking statements included in this press release are made as of the date here of only, based on information available to the company as of the date hereof, and, subject to any applicable law to the contrary, the company assumes no obligation to update any forward-looking statements.

Par Pharmaceutical Companies, Inc.
http://www.parpharm.com

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