OTC drugs news from FierceBiotech

Just before Biogen Idec announced it was out of the merger business, for the present, Merck's CEO was telling the Wall Street Journal that it had Read more...

Zila is handing out pink slips to 20 workers as it restructures its business. The small, Phoenix-based company sells oral cancer detection kits. It says the restructuring will save about $3 million a... Read more...

An FDA approval of any kind is often the trigger to a massive advertising blitz, but ad experts say that Barr Pharmaceuticals is likely to stay focused on a discreet, tailored campaign while talking directly with healthcare professionals. Barr notes that the agreement with the FDA also limits sales of the contraceptive to pharmacies and clinics, so a major branding campaign hardly makes sense.

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After three years of regulatory limbo, Barr Laboratories has won the right to market the Plan B contraceptive without a prescription. Women over 18 will be required to show proof of their age to buy the drug while under age girls will still need a prescription. Plan B has been a favorite cause on both sides of the political divide. Opponents say that OTC access of what it calls an "abortion pill" would encourage promiscuity and further spread sexually transmitted diseases while backers …

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After a lengthy wait, the FDA and Barr Pharmaceuticals have come up with an agreement that clears the way for the over-the-counter sale of the contraceptive Plan B. Under the agreement, Barr will sell Plan B OTC to women over the age of 18 while women under that age will be required to have a prescription. The agency has been sitting on this decision for more than two years, leading several U.S. senators to vow to indefinitely hold up Dr. Andrew von Eschenbach's appointment to head the …

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In what could mark a major breakthrough in the impasse over Plan B, the FDA has indicated that it may move ahead and make the controversial contraceptive available over-the-counter for women 18 and older. In a letter to Barr Pharmaceuticals, the agency asked what steps could be taken to ensure that underage girls don't obtain it and that a final decision was being sought in a matter of weeks. The morning-after pill has proved to be a major stumbling block at the FDA. A number of Democrats …

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J&J buys Pfizer's OTC division for $16.6B

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Clearing the way to focus more on its prescription drug business, Pfizer has agreed to sell its OTC division to Johnson & Johnson for $16.6 billion in cash. The OTC therapies include such market stalwarts as Sudafed and Visine and collectively earned $3.9 billion in revenue last year. J&J also won the OTC rights to Zyrtec when it loses patent protection. Pfizer also said it would buy back up to $17 billion in shares. Shares of Pfizer were buoyed slightly be the news.

- here's the AP report on the sale

A bullish GlaxoSmithKline is preparing a bid of about $15 billion for Pfizer's over-the-counter drug division, according to a variety of news reports. The division includes such OTC standards as Sudafed and Listerine. Revenue in 2004 neared $4 billion.

- read the article on GSK from MarketWatch

Daiichi Sankyo has inked a deal to buy the OTC unit of Astellas--Zepharma--for 20 billion yen. Report