FDA Approves Botox, Causes Upbeat for Allergan

The Food and Drug Administration approves Botox for crow's feet but the decision resulted to a bit of upbeat news for Allergan, according to Fierce Pharma.

Brand Allergan has faced some tough news in the recent months and the new FDA approval for Botox is said to provide something for executives to smile about, even if it is just intended for cosmetic use on crow's feet.

The Irvine, CA-based company said with the FDA approval, Botox Cosmetic is the first and only drug of its kind to temporarily treat moderate to severe lateral canthal lines, commonly known as "crow's feet" lines.

When Allergan last year talked about seeking approval in this category, analysts predicted the market could add about $100 million in sales for the drug, which was approved in 2002 for cosmetic use on frown lines between the brows.

In June, Allergan was blindsided by FDA draft guidance that would allow generics of its eye drug Restasis into the market without clinical testing, years ahead of what anyone expected. That put a huge damper on its shares because, at $792 million in sales last year, Restasis was Allergan's best-selling product.

The company last month asked the FDA to set a higher bar for approving generic versions by requiring testing in humans. The company is arguing that generic versions can't be deemed bioequivalent unless they're tested in patients and that the FDA's proposal to permit only lab testing is contrary to the agency's past position.

In April, the FDA refused to approve its new migraine drug because of manufacturing problems. And in August, Allergan lost two patents in India. India's patent appeals board revoked the patents covering glaucoma treatments Ganfort and Combigan, both used to reduce pressure inside the eye, following a patent challenge from domestic drugmaker Ajanta Pharma.