Please refer to the gamma Core Instructions for Use for all important warnings and precautions before using or prescribing this product.
(NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
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Lipocine resubmitted the NDA to the FDA in based on the results of the DV study.
The DV study confirmed the efficacy of TLANDO with a fixed dose regimen without the need for dose adjustment.
Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, the risk that BRUDAC may make a negative recommendation to the Commissioner of the FDA with respect to TLANDO, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including that the FDA will determine there are deficiencies in our resubmitted NDA, the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at gov.
Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
Designed as a portable, easy-to-use technology, gamma Core can be self-administered by patients, as needed, without the potential side effects associated with standard of care. for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.
When placed on a patient's neck over the vagus nerve, gamma Core stimulates the nerve's afferent fibers, which may lead to a reduction of pain in patients. gamma Core is currently available outside of the U.
Although the FDA will consider the recommendation of BRUDAC, the final decision regarding the approval of TLANDO is made by the FDA solely, and the recommendations by BRUDAC are non-binding. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies.
Lipocine's clinical development pipeline includes three development programs TLANDO, LPCN 1111 and LPCN 1107.
As seen in other published studies, gamma Core was well tolerated, as demonstrated by a low incidence of device-related adverse effects.