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Par Formulations' First FDA Nod

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Par Formulations Private Limited, the operating subsidiary of Par Pharmaceuticals Companies Inc. (:PRX) received its first approval from the US Food and Drug Administration (:FDA). The FDA approved the company’s abbreviated new drug application (ANDA) for its generic version of hypertension drug Trandate (labetalol).

Trandate was originally a part of GlaxoSmithKline's (GSK) portfolio. Glaxo subsequently divested Trandate to Aspen Pharmacare Holdings Ltd. Par Formulations expects to start shipping its generic version of Trandate in August 2012.

Par Pharma's generic version will be available in 100 mg, 200 mg and 300 mg dosages. The tablets can be taken either solely or together with antihypertensive agents like thiazide and diuretics.

Par Formulations was formed following Par Pharma’s February 2012 acquisition of India-based Edict Pharmaceuticals. Par Pharma had acquired Edict Pharma for $20.5 million along with a debt repayment of $4.4 million. The acquisition has expanded Par Pharma’s R&D efforts and manufacturing capabilities.

As of March 31, 2012, Par Pharma had 71 ANDAs filed with the FDA representing more than $20 billion of combined branded product sales. These ANDA filings include 21 first-to-file opportunities.

We currently have a Neutral recommendation on Par Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short run. Par Pharma was in the news recently with the company announcing that it has entered into an agreement with an affiliate of leading global private equity firm TPG Capitals, whereby TPG will acquire Par Pharma for $1.9 billion.

However, the agreement also permits Par Pharma’s Board of Directors to search for alternative superior proposals until August 24, 2012, from other bidders. Prospective suitors could include other generic players or ex-US companies looking to strengthen their presence in the US. If no alternative offer turns up, the TPG deal is expected to go through in 2012.

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