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Biotech Stocks Facing FDA Decision In April

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We are one quarter into 2019. As we head to April, it's time to take a look back at some of the regulatory news that made headlines in March.

On March 12, the FDA approved a new generic Valsartan, developed by Alkem Laboratories Ltd. The ongoing recall of certain lots of Valsartan has resulted in a shortage, and the FDA has prioritized the review of generic applications for Valsartan products.

Unless you've been living under a rock, you have probably heard about the ongoing recall of blood pressure drug Valsartan over cancer concerns.

On March 19, the FDA approved the first drug for women suffering from postpartum depression - Zulresso, developed by Sage Therapeutics (SAGE). No doubt, the approval marks an exciting milestone in women's mental health. But the therapy's hefty price of $34,000 per course of treatment raises the question of affordability.

So far this year, 4 novel drugs have been approved in the U.S., including Zulresso.

On March 19, the FDA issued warning letters to two breast implant manufacturers, Mentor Worldwide and Sientra, for failure to comply with post-approval study requirements. Individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

Last year, 313,735 women underwent breast augmentation, up 4 percent from 2017, according to the American Society of Plastic Surgeons.

A two-day meeting focusing on the long-term potential health effects of breast implants kicked off on March 25. The U.S. National Breast Implant Registry is expected to be launched on July 1, 2019.

Albeit a bit off-topic, here's what happened at the FDA on a more official front in March.

On March 5, the FDA commissioner Scott Gottlieb announced that he will be quitting office beginning in April. He had assumed office as the 23rd commissioner on May 11, 2017. Norman (Ned) E. Sharpless, director of the National Cancer Institute has been named as acting commissioner of the FDA, following Gottlieb's resignation.

Now, let's take a look at the companies that await a ruling from the FDA in April 2019.

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