Pharmacy Industry News: FDA approves Perrigo OTC Minoxidil Foam | Pharmacy Industry News

Pharmacy Industry News: FDA approves Perrigo OTC Minoxidil Foam

FDA approves Perrigo OTC Minoxidil Foam

The US Food and Drug Administration (FDA) has approved Perrigo’s over-the-counter (OTC) Minoxidil Foam’s abbreviated new drug application (ANDA).

Perrigo ‘s Minoxidil Foam is the generic version of Men’s Rogaine Foam, used to regrow hair on the top of the scalp.

Earlier, GSK company Stiefel Research Australia had filed a lawsuit against Perrigo on Minoxidil Foam ANDA, which has been settled in February 2011.

According to the settlement agreement, Perrigo has received rights to launch the generic version of Men’s Rogaine Foam in the US on 1 March 2012, or earlier, under certain circumstances.

Perrigo chairman and CEO Joseph Papa said this is another example of Perrigo’s commitment to bring new products to market.

J&J pulls submission for Zeltia’s Yondelis

Zeltia has suffered a setback with the news that partner Johnson & Johnson has withdrawn a filing with US regulators for the Spanish drugmaker’s cancer treatment Yondelis.

J&J’s Centocor Ortho Biotech unit announced that it has voluntarily withdrawn the New Drug Application for Yondelis (trabectedin) for the treatment of recurrent ovarian cancer. The decision is based on the US Food and Drug Administration’s recommendation that an additional Phase III study be conducted.

In September 2009, the FDA issued a complete response letter regarding the NDA for Yondelis when administered in combination with J&J’s Doxil (doxorubicin). The agency wanted to see overall survival data from the pivotal OVA-301 trial and additional clinical pharmacology studies.

J&J noted that the OVA-301 overall survival data will be presented in June at the annual meeting of the American Society of Clinical Oncology, adding that it is evaluating the development programme for Yondelis in recurrent ovarian cancer: the US healthcare giant recently initiated a Phase III study with trabectedin for metastatic L-sarcoma.

Last week, Zeltia was hit by the news that the National Institute for Health and Clinical Excellence rejected the Yondelis/Doxil combo for use in ovarian cancer patients because it had concerns over its efficacy compared with standard therapies; it was approved for ovarian cancer in Europe in November 2009 and has been available for the treatment of advanced soft tissue sarcoma since September 2007

Top 10 Pharma CEO salaries of 2010

Welcome to our annual look at the biggest CEO in the pharma industry. Despite a year fraught with manufacturing issues and drug recalls, Johnson & Johnson CEO Bill Weldon takes the top spot, with $28.7 million in 2010 pay. And Novartis’ Daniel Vasella grabs the number two spot thanks to a lucrative golden handshake.

Next year we’ll have to say goodbye to a few familiar faces that are making their final appearance on this list. Pfizer’s Jeff Kindler won’t be back next year, nor will Vasella or Richard Clark of Merck. All of these CEOs will be replaced by new executives that will appear on the list. For example, Ian Read, Pfizer’s new CEO, earned more than $17 million last year, even though he didn’t become CEO until Dec. 5. George Scangos, formerly of Exelixis and now Biogen Idec CEO, was paid $9.4 million last year–and he didn’t come on board until more than halfway through the year.

Others are waiting, too. Allergan’s David Pyott ($12.7 million), Bristol-Myers Squibb’s Lamberto Andreotti ($11.8 million) and Baxter’s Robert Parkinson ($11.5 million) were close to making the list. Click below to get all the details on the top 10 highest paid biotech and pharma CEOs of 2010.

1. Bill Weldon – J&J – $28.7M

2. Daniel Vasella – Novartis – $27M

3. Miles White – Abbott- $25.6M

4. Jeffrey Kindler – Pfizer- $24.7M

5. Richard Clark – Merck – $24.6M

6. Robert Coury – Mylan – $22.9M

7. Kevin Sharer – Amgen – $21.1M

8. James Mullen – Biogen Idec – $20M

9. John Lechleiter – Eli Lilly – $16.5M

10. John Martin – Gilead Sciences – $14.2M

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