Recently, Mylan Inc.‘s (MYL) subsidiary, Matrix Laboratories received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) capsules in two dosage forms (15 mg and 30 mg). Mylan plans to begin shipment of the product immediately.  The drug is the generic version of Takeda Pharmaceuticals' (TKPHY.PK) proton pump inhibitor Prevacid DR Capsules. According to IMS Health (RX), the branded version had US sales of approximately $3 billion for the 12 months ending June 30.  Mylan received quite a few approvals in the recent past. In October, Mylan settled its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole), following which Mylan received the approval to launch the generic version of the drug. Additionally, in September, Mylan received FDA approval for its generic version of Bristol-Myers Squibb's (BMY) Sinemet ...

For Immediate Release

Chicago, IL – August 31, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Mylan (MYL), Sanofi-Aventis (SNY), Gilead Sciences (GILD), GlaxoSmithKline (GSK) and Freddie Mac (FRE).

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Here are highlights from Friday’s Analyst Blog:

Mylan’s Portfolio Strengthens

We are pleased to hear that Mylan (MYL) has begun to market the generic version of BenzaClin (1% Clindamycin and 5% Benzoyl Peroxide Gel) for acne treatment, which was originally manufactured by Sanofi-Aventis (SNY). The drug has been developed under an agreement between its subsidiary,

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We are pleased to hear that Mylan (MYL) has begun to market the generic version of BenzaClin (1% Clindamycin and 5% Benzoyl Peroxide Gel) for acne treatment, which was originally manufactured by Sanofi-Aventis (SNY). The drug has been developed under an agreement between its subsidiary, Mylan Pharmaceuticals and Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International.

Earlier this month, Dow received the US Food and Drug Administration (FDA) approval for the generic drug. Although the approval is good news for the company, we do not expect it to contribute significantly to the top line since BenzaClin had total U.S. sales of about $221 million for the 12 months ending June 30 (as per IMS data).

This is the third approval for Mylan in the month of August. A few days back, Mylan’s subsidiary Matrix Laboratories received tentative approval from the FDA under the President's Emergency Plan for AIDS Relief

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Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Clinical Data [CLDA: 11.83, -0.23 (-1.91%)] announced positive top-line results on 6/2/09 from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary

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Gilead's Strong Fundamentals Should ContinueBusiness continues to look strong for Gilead Sciences (GILD). The company's tenofovir-based HIV products (Viread, Truvada and Atripla) are number one and widening their lead. The clinical data continues to support the switching of patients from older generation molecules such as abacavir and lamivudine to Gilead's franchise. Also driving impressive trends are revised HIV treatment guidelines from the U.S. Department of Health and Human Services recommending only Truvada (and Atripla) as the backbone of choice in naïve patients.These new guidelines, put into place in November 2008, downgraded Epzicom to an alternative medication based on cardiovascular risk and high rates of virologic failure. Finally, the new FDA chief, Margaret Hamburg, a former New York City Health Commissioner, has significant experience in combating infectious disease, such as HIV/AIDS, and we believe that this type of focused leadership only further adds to the ...