FDA Approves Avanir and Forest Labs Treatments for PBA and Bacterial Infections

FDA Ends October With Drug Approvals

BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).

Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.

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

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

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

Questcor: FDA Delays Drug Approval

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Questcor: FDA Delays Drug Approval

Questcor announced late Wednesday that the U.S. Food and Drug Administration has delayed for the second time an approval decision for the company's drug Acthar as a treatment for infantile spasms.

A new approval date has not been announced but Questcor said FDA's review will extend beyond the current Sept. 11 deadline because regulators need more time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the infantile spasms indication.

FDA Alert Questcor Pharma

FDA Decision Alert: Questcor Pharma

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(RTTNews) - In less than a week, the Food and Drug Administration will take a final decision on Questcor Pharmaceuticals Inc.'s (QCOR) H.P. Acthar Gel for the proposed expanded indication of infantile spasms.

The regulatory agency was originally scheduled to rule on Acthar's expanded indication in June. But the deadline was extended in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor.