21 Drugs Facing FDA Approval Decisions

BOSTON ( TheStreet) -- The fall will be a very busy time for U.S. drug approvals.

For this latest update to my regulatory calendar, I count 21 drugs (impacting 27 different drug and biotech companies) with approval applications to be decided before year's end by the regulators at the U.S. Food and Drug Administration.

In October alone, the FDA is expected to render approval decisions on 10 drugs.

This FDA regulatory calendar includes information on both drug-approval decisions dates as well as dates for any upcoming FDA drug advisory panels. Stocks are listed in chronological order, based on the nearest regulatory catalyst.

Questcor Pharmaceuticals ( QCOR)

Drug/indication: Acthar for infantile spasms

Approval decision date: Sept. 11, 2010

Recent stock performance:At $10.69, the stock is just below its 52-week high of $11.63 reached July 30.

An FDA advisory panel said Acthar was safe and effective as a treatment for infant spasms at a meeting on May 6. The original FDA approval decision date of June 11 was extended by three months so that the agency could drug labeling and post-approval commitments.

Savient Pharmaceuticals ( SVNT)

Drug/indication: Krystexxa for gout

Approval decision date: Sept. 14, 2010

Recent stock performance:At around $14, the stock is up about 30% since early June.

The FDA refused to approve Krystexxa last August, citing problems with the way the drug is manufactured. Savient revised the Krystexxa manufacturing process and submitted a response in March to the FDA's complete response letter.

Alkermes ( ALKS)

Drug/indication:Vivitrol for opioid addiction

FDA advisory panel: Sept. 16, 2010

Approval decision date: Oct. 12, 2010

Recent stock performance:At just under $14, the stock is up about 45% for the year.

If approved, Vivitrol will be the first long-acting, non-narcotic treatment for patients addicted to opioids. Alkermes currently sells a version of Vivitrol for alcholol dependence.

Arena Pharmaceuticals ( ARNA)

Drug/indication: Lorcaserin for obesity

FDA advisory panel: Sept. 16, 2010

Approval decision date: Oct. 22, 2010

Recent stock performance: At just under $7, the stock has more than doubled since June due to the signing of a marketing partnership with Eisai and the setback to competitor Vivus.

Lorcaserin is one of three obesity drugs currently under review by FDA.

Roche

Drug/indication: Avastin for metastatic breast cancer

Approval decision date: Sept. 17, 2010

FDA will decide whether or not to revoke Avastin's approval in breast cancer based on phase III data that failed to demonstrate a survival benefit for patients. Roche has argued that Avastin does benefit breast cancer patients despite the lack of prolonged survival, although a recent FDA advisory panel disagreed.

Novartis ( NVS)

Drug/indication: Gilenia for multiple sclerosis

Approval decision date: Sept. 21, 2010

Recent stock performance:Shares are down about 5% for the year.

An FDA advisory panel said Gilenia was safe and effective as a treatment for multiple sclerosis, at a meeting on June 10. If approved, Gilenia would be the first multiple sclerosis drug administered as a pill, and as such, the drug could have an impact on already approved, injectable MS drugs from Biogen Idec ( BIIB), Teva ( TEVA) and Merck-Serono.

Hospira ( HSP)

Drug/indication: Dyloject for acute moderate-to-severe pain in adults

Approval decision date: Oct. 3, 2010

Recent stock performance: At $51, shares are down 15% since hitting a year-high in mid-July.

If approved, Dyloject will be the first IV nonsteroidal anti-inflammatory drug (NSAID) marketed in the U.S. as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. The active ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID. Dyloject was developed by Javelin Pharmaceuticals, which Hospira acquired in July.

Human Genome Sciences ( HGSI)

Drug/indication: Zalbin for hepatitis C

Approval decision date: Oct. 4, 2010

Recent stock performance: At just under $30, the stock has rebounded 35% off its July low but is still just flat for the year.

In June, Human Genome Sciences said approval of Zalbin was unlikely after the FDA expressed concerns about the risk-benefit of the drug. Zalbin is a longer-acting formulation of interferon that can be dosed as infrequently as every two weeks for the treatment of hepatitis C. Currently approved long-acting interferons require once-weekly dosing.

Alexza Pharmaceuticals ( ALXA)

Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder

Approval decision date: Oct. 11, 2010

Recent stock performance: At around $3, stock is still far from the 52-week high of nearly $4 reached in May.

AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine, intended for the rapid treatment of adults with schizophrenia or bipolar disorder. Biovail ( BVF) will market AZ-004 in the U.S. and Canada, if approved.

Jazz Pharmaceuticals ( JAZZ)

Drug/indication: JZP-6 for fibromyalgia

Approval decision date: Oct. 11, 2010

Recent stock performance: Shares tumbled to around $8.50 from more than $10 after the negative FDA advisory panel vote.

On July 20, an FDA advisory panel voted against approval of JZP-6 due to unacceptable risks of the drug being misused and potentially abused. JZP-6 contains the same active ingredient as Xyrem, which Jazz currently markets in the U.S. as a treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.

Amylin Pharmaceuticals ( AMLN), Alkermes and Eli Lilly ( LLY)

Drug/indication:Bydureon for diabetes

Approval decision date:Oct. 22, 2010

Recent stock performance: At just over $20 a share, Amylin is up 43% for the year.

This is the second FDA review cycle for Bydureon, a once-weekly injectable drug for diabetes.

Vivus ( VVUS)

Drug/indication: Qnexa for obesity

Approval decision date: October 28, 2010

Recent stock performance: At $5.61, Vivus' value was cut in half by the negative FDA advisory panel vote.

The odds in favor of Qnexa's approval took a big hit in July when an FDA advisory panel voted against the drug's approval due to a lack of long-term safety data. Vivus is expected to announce results from a two-year safety study of Qnexa in the third quarter.

Biodel ( BIOD)

Drug/indication: VIAject for diabetes

Approval decision date: Oct. 29, 2010

Recent stock performance: Closed Friday at $3.88. The stock has traded as low as $3.22 and as high as $6.25 this year.

VIAject is a fast-acting insulin analogue designed for absorption into the bloodstream faster than currently marketed rapid-acting insulins.

Avanir Pharmaceuticals ( AVNR)

Drug/indication: Zenvia for pseudobulbar effect

Approval decision date:: Oct. 30, 2010

Recent stock performance: At $3.04, stock is off its July high of $3.73.

FDA rejected Zenvia in 2006. Avanir conducted a new phase III study using a lower dose of the drug and resubmitted to FDA for another review.

Cadence Pharmaceuticals ( CADX)

Drug/indication: Ofirmev for pain/fever

Approval decision date: Nov. 4, 2010

Recent stock performance: At $8.21, stock is down 21% from its April high.

This is the second review cycle for Ofirmev following an FDA complete response letter issued in February.

Amgen ( AMGN)

Drug/indication:Prolia for bone complications in cancer patients

Approval decision date: Nov. 18, 2010

Recent stock performance: Amgen is down 8% for the year.

Prolia was previously approved as a treatment for osteoporosis. Amgen is seeking additional approvals for Prolia in various cancer indications.

Cumberland Pharmaceuticals ( CPIX)

Drug/indication:Acetadote for non-acetaminophen acute liver failure

Approval decision date: December 2010

Recent stock performance: At $4.92, stock is trading at its lows for the year.

The FDA review was extended three months beyond its original August approval date.

Orexigen Therapeutics ( OREX)

Drug/indication: Contrave for obesity

FDA advisory panel: Dec. 7, 2010

Approval decision date: Jan. 31, 2011

Recent stock performance: At 4.73, the stock is starting to lift off its July low of $3.81.

Orexigen is the third company, after Vivus and Arena, to bring its obesity drug in front an FDA advisory panel.

Human Genome Sciences

Drug/indication: Benlysta for lupus

Approval decision date: Dec. 9, 2010

If approved, Benlysta would be the first new drug for lupus patients in 50 years. GlaxoSmithKline will co-market Benlysta.

Bristol-Myers Squibb ( BMY)

Drug/indication: Ipilimumab for melanoma

Approval decision date: Dec. 25, 2010

Recent stock performance: Stock is up 3% for the year.

Bristol is seeking initial approval for Ipilimumab for patients who have previously received treatment for melanoma.

Mannkind ( MNKD)

Drug/indication: Afrezza for diabetes

Approval decision date: Dec. 29, 2010

Recent stock performance: At $5.87, stock has lost almost half its value since March.

This is the second review cycle for Afrezza, a small, inhaled insulin device for diabetes.

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. 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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