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FDA Ends October With Drug Approvals, Rejection

Updated throughout, including information on the FDA rejection of Biodel's fast-acting insulin.

BOSTON ( TheStreet) -- U.S. regulators ended October with two drug approvals and a rejection, clearing an antibiotic from Forest Labs (FRX) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals (AVNR) but rejecting a fast-acting insulin from Biodel (BIOD).

October was a busy but tough month for new drug approvals at FDA. Regulators rejected eight new drugs, including two different diabetes drugs from Amylin Pharmaceuticals (AMLN) and Biodel, and weight-loss drugs from Arena Pharmaceuticals (ARNA - Get Report) and Vivus (VVUS - Get Report), respectively.

FDA approved four drugs, the two mentioned above plus drugs from Questcor Pharmaceuticals (QCOR) and Alkermes (ALKS).

On Monday, FDA rejected Biodel's Linjeta, telling the company that data submitted was not sufficient for approval and that two new clinical studies, one each in Type 1 and Type 2 diabetics, would be necessary if regulators were to consider the drug for approval again. FDA is also seeking more information from Biodel about the manufacturing of Linjeta.

Biodel shares were down more than 50% to $1.68 in Monday pre-market trading.

The Forest Labs injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.

"These are serious and potentially life-threatening infections for which new treatment options are needed. FDA is committed to facilitating new antibiotic drug development," said Edward Cox, the director of FDA's Office of Antimicrobial Products, in a statement.

Forest expects to launch Teflaro in January 2011.

The Avanir drug, Nuedexta, was approved as the first treatment for pseudobulbar affect (PBA) a neurological condition in which patients suffer from uncontrollable outbursts of laughing or crying. Most patients who suffer from PBA are also diagnosed with other neurological disorders like multiple sclerosis or Lou Gehrig's disease.

Avanir won Nuedexta's approval after a lengthy delay brought on by FDA concerns that the drug coud cause serious heart rhythm disruptions. Avanir reformulated Neudexta at a lower dose and conducted another safety study to assuage FDA concerns.

FDA approved Nuedexta without a so-called black box warning but the label does warn doctors to avoid using the drug in certain patients with heart problems and to monitor patients initially to guard against arrhythmias. The FDA did not release a statement regarding Nuedexta's approval.

Canaccord Genuity analyst Ritu Baral forecasts Nuedexta peak sales of $350 million in the U.S. and another $300 million in Europe, if the drug is approved there in several years. She has a buy rating and a $9 price target on Avanir.

Monday, Jefferies raised its price target on Avanir to $15, citing the "scarcity value" of approved neurological drugs like Nuedexta as a potential inducement for a takeover.

Avanir bears who were burned Friday by Nuedexta's approval also contend that Avanir exaggerates Nuedexta's commercial potential, believing the drug will only garner about $50 million in U.S sales.

Avanir shares closed Friday at $2.42 but doubled in price to $5 in the after-hours session upon news of Nuedexta's approval.

Other upcoming FDA drug approval decisions:

Nov. 4: Cadence Pharmaceuticals' (CADX) Ofirmev for fever and pain indications.

Nov. 18: Amgen's (AMGN - Get Report) Prolia to treat bone complications due to cancer therapy.

--Written by Adam Feuerstein in Boston.

>To contact the writer of this article, click here: Adam Feuerstein.

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Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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