Covidien Wins FDA Approval

International health care product major, Covidien plc. (COV) recently revealed approval from the Food and Drug Administration (“FDA”) for Gablofen (baclofen injection) in syringes that are prefilled. These syringes were designed to cut down on preparation time and make it easier for patients on Intrathecal Baclofen Therapy. This drug is used to treat spastics traced to spinal and cerebral causes.

According to the company, the new syringes may replace the older glass ones and render the pump refilling process easier to manage. Prefilled syringes of Gablofen will be marketed from February 2013. The drug will be sold in vials in different concentrations.

Covidien is a leading global health care product manufacturing company that develops and markets medical solutions for better patient outcomes. It has a history of developing and manufacturing high-quality products in a cost-effective manner. Covidien continues to expand both organically as well as inorganically, despite a challenging Med-tech environment.

We see opportunities for multiple expansion, based on the strength and diversity of the company's business and its ability to grow on the back of strategic investments and portfolio reshaping initiatives toward high-growth/high-margin businesses. Additionally, the exit of a competitor has created opportunities for the company to gain market share in the U.S.

Further, Covidien remains committed to delivering incremental returns to its investors. The company raised its commitment to return more than 50% of its free cash flow to shareholders via dividends and share repurchases.

Covidien embarked on an acquisition spree to scoop up several new companies for the diversification and development of new products/technologies. Although we believe that the company’s acquisitions will pay off in the long term, we remain cautious about the near-term dilution associated with the company’s acquisitions.

Earlier, in October 2012, Covidien’s Pharmaceuticals business, Mallinckrodt, acquired CNS Therapeutics Inc., a St. Paul Minnesota-based specialty pharmaceutical company, for roughly $100 million. Covidien plans to spin-off its Pharmaceutical business by mid-2013 to focus on its high-margin surgical products portfolio.

The company's product offerings under its larger Medical Device segment are similar to some of its competitors like Johnson & Johnson (JNJ), Becton, Dickinson and Company (BDX) and CR Bard Inc. (BCR).

Covidien currently carries a Zacks Rank #3 (Hold).

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