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Home Industry News Abbott antibiotic approved by FDA for generic manufacture

Abbott antibiotic approved by FDA for generic manufacture

22nd May 2006

The FDA has announced it has approved a generic form of Abbott Laboratories’ Omnicef antibiotic to treat mild to moderate infections.

Omnicef was approved in 1997 for use with bacterial infections,such as pneumonia, bronchitis, tonsillitis and skin infections, according to Drugs.com. However, the drug’s patent does not expire until 2007.

Laureen Cassidy, a spokeswoman for Abbott, told the Dow Jones Newswires: “Abbott will enforce its patents on Omnicef as appropriate.”

Larry Biegelsen, an analyst for Prudential Securities, revealed to the same news provider that generic competition for could have an affect on Abbott’s earnings-per-share in the years following 2007.

He said: “Although this is a negative development, we think this is a manageable one for Abbott.”

Abbott markets the drug as an antibiotic safe for use in children in its strawberry-flavoured soluble form, which is not affected by the FDA’s decision. Omnicef is a third-generation cephalosporin, which is a class of antibiotics first launched for use in 1964. Third-generation cephalosporins are described as broad-spectrum antibiotics which are more effective against gram-negative bacteria than the two previous generations, although less effective against gram-positive bacteria.

They are shown to be effective against some strains of Staphylococcus aureus, the bacteria responsible for MRSA, the hospital ‘superbug’, as well as meningitis-causing bacteria.

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