BOSTON (

TheStreet

) -- I've updated the 2011 FDA drug approval calendar.

For easy reference, I've organized this regulatory calendar in chronological order based on the drug approval decision date. I've also included information on pending FDA advisory panels. At the end of the calendar is a list of companies with potential regulatory milestones in 2011 based on expected but not yet completed drug approval filings.

This FDA drug approval calendar updates and expands a similar calendar published in December.

Pfizer

(PFE) - Get Report

and

Protalix Biotherapeutics

(PLX) - Get Report

Drug/indication:

Uplyso for Gaucher's disease

Approval decision date:

Feb. 25, 2011

Salix Pharmaceuticals

(SLXP)

Drug/indication:

Xifaxan for irritable bowel syndrome

Approval decision date:

March 7, 2011

Xiafaxan is already approved for travelers' diarrhea and hepatic encephalopathy.

Human Genome Sciences

(HGSI)

Drug/indication:

Benlysta for lupus

Approval decision date:

March 10, 2011

If approved, Benlysta would be the first new drug for lupus patients in 50 years.

GlaxoSmithKline

(GSK) - Get Report

will co-market Benlysta. The FDA's approval decision date was pushed back three months from Dec. 9, 2010.

Bristol-Myers Squibb

(BMY) - Get Report

Drug/indication:

Yervoy (ipilimumab) for melanoma

Approval decision date:

March 26, 2011

FDA cancelled and has no plans to reschedule an advisory panel meeting originally set for Feb. 9. Bristol is seeking initial approval for ipilimumab for patients who have previously received treatment for melanoma.

Dendreon

(DNDN)

Drug/indication:

Provenge for prostate cancer (manufacturing expansion)

Approval decision date:

March 2011

Dendreon is seeking FDA approval to expand Provenge manufacturing capacity at its New Jersey facility. Two additional Provenge plants are under construction outside Atlanta and in Orange Country, Calif. that are expected to come on line in the middle of the year.

Cell Therapeutics

(CTIC) - Get Report

Drug/indication:

Pixantrone for aggressive non-Hodgkin's lymphoma

Approval decision date:

First quarter 2011

Cell Therapeutics filed an appeal with FDA contesting the agency's April 2010 rejection of pixantrone.

Forest Laboratories

(FRX)

Drug/indication:

Daxas for chronic obstructive pulmonary disorder

Approval decision date:

First quarter 2011

This is the second FDA review cycle for Daxas.

Optimer Pharmaceuticals

Drug/indication:

Fidaxomicin for Clostridium difficile infection

FDA advisory panel date:

April 5, 2011

FDA approval decision date:

May 30, 2011

Xenoport

(XNPT)

and

GlaxoSmithKline

(GSK) - Get Report

Drug/indication:

Horizant for restless leg syndrome

Approval decision date:

April 6, 2011

This is the second FDA review cycle for Horizant. The original new drug application was filed to FDA in January 2009.

Spectrum Pharmaceuticals

(SPPI) - Get Report

Drug/indication:

Fusilev for colon cancer

Approval decision date:

April 29, 2011

This is the second review for Fusilev in colon cancer. The drug is already approved as a treatment for a form of bone cancer.

Merck

(MRK) - Get Report

Drug/indication:

Boceprevir for Hepatitis C

Approval decision date:

May 2011

Merck will not disclose the exact FDA approval decision date, but it's likely the first two weeks of May. An FDA advisory panel scheduled for April 27-28 is a likely venue for a boceprevir review.

Vertex Pharmaceuticals

(VRTX) - Get Report

Drug/indication:

Telaprevir for Hepatitis C

Approval decision date:

May 23, 2011

An FDA advisory panel scheduled for April 27-28 is a likely venue for a telaprevir review.

King Pharmaceuticals

(KG)

and

Acura Pharmaceuticals

(ACUR)

Drug/indication:

Acurox, an abuse-resistant, immediate-release opioid.

Approval decision date:

June 17, 2011

Pain Therapeutics

(PTIE)

,

Durect Corp.

(DRRX) - Get Report

and

King Pharmaceuticals

(KG)

Drug/indication:

: Remoxy, a abuse-resistant opioid for moderate to severe pain.

Approval decision date:

June 23, 2011

Seattle Genetics

(SGEN) - Get Report

Drug/indication:

brentuximab vedotin for Hodgkin's lymphoma

Approval decision date:

Third quarter 2011 (estimated, based on the company's forecast for a first-quarter 2011 approval filing.)

Transcept Pharmaceuticals

(TSPT)

Drug/indication:

Intermezzo for insomnia

Approval decision date:

July 14, 2011

This is the second FDA review for Intermezzo following a complete response letter in October 2009.

NuPathe

(PATH)

Drug/indication:

Zelrix, a transdermal patch for migraines.

Approval decision date:

Aug. 29, 2011

Adventrx Pharmaceuticals

(ANX)

Drug/indication:

ANX-530 (exelbine) for non-small cell lung cancer

Approval decision date:

Sept. 1, 2011

ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The FDA issued a refuse-to-file letter for ANX-530 in 2010.

MELA Sciences

(MELA)

Device/indication:

MELAFind for diagnosis of melanoma

Approval decision date:

Unknown

FDA rejected MELAFind in March 2010 but an FDA advisory panel in November narrowly recommended the device's approval over the FDA's objection. The FDA has not said when it will issue another approval decision for MELAFind.

Additional drugs with potential regulatory milestones in 2011:

Onyx Pharmaceuticals

(ONXX)

Drug/indication:

carfilzonib for multiple myeloma

Status:

FDA approval filing expected mid-2011

Alimera Sciences

(ALIM) - Get Report

and

pSivida

(PSDV)

Drug/indication:

Iluvien for diabetic macular edema

Status:

FDA rejected Iluvien in December; Alimera intends to resubmit for approval this year based on new, longer-term data.

Genzyme

(GENZ)

and

Isis Pharmaceuticals

(ISIS)

Drug/indication:

mipomersen for severe hypercholesterolemia

Status:

Genzyme is in the process of being acquired by Sanofi-Aventis, which may affect the regulatory timelines for mipomersen. Genzyme had previously suggested that the mipomersen approval filing could be delayed until the second half of 2011, from the previous estimate of a filing in the first half 2011.

MAP Pharmaceuticals

(MAPP)

Drug/indication:

Levadex for migraines

Status:

MAP intends to file for Levadex approval in the first half of 2011.

Vivus

(VVUS) - Get Report

Drug/indication:

Qnexa for obesity

Status:

FDA rejected Qnexa in October. Vivus intends to resubmit Qnexa to FDA in 2011.

Amylin Pharmaceuticals

(AMLN)

,

Alkermes

(ALKS) - Get Report

and

Eli Lilly

(LLY) - Get Report

Drug/indication:

Bydureon for diabetes

Status:

Additional clinical work required by FDA after October rejection is ongoing. Resubmission expected by end of 2011.

Alexza Pharmaceuticals

(ALXA)

Drug/indication:

AZ-004 for agitation in patients with schizophrenia or bipolar disorder

Status:

Alexza plans to resubmit AZ-004 to FDA in July 2011.

--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;

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