NEWARK, CA, USA I May 31, 2013 I Depomed, Inc. (DEPO), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to the New Drug Application for SEFELSA, Depomed’s investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.
The CRL states that the FDA cannot approve the application in its present form. Based on the letter, Depomed does not currently intend to further invest in SEFELSA.
“The CRL was expected in light of the SEFELSA FDA Advisory Committee meeting,” said Jim Schoeneck, President and Chief Executive Officer. “Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with revenues from two marketed products, Gralise and Zipsor, significant royalty income from our partnered products and technology, a strong balance sheet and potential to turn cash flow positive in the second half of this year.”
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
SOURCE: Depomed
Post Views: 139
NEWARK, CA, USA I May 31, 2013 I Depomed, Inc. (DEPO), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to the New Drug Application for SEFELSA, Depomed’s investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.
The CRL states that the FDA cannot approve the application in its present form. Based on the letter, Depomed does not currently intend to further invest in SEFELSA.
“The CRL was expected in light of the SEFELSA FDA Advisory Committee meeting,” said Jim Schoeneck, President and Chief Executive Officer. “Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with revenues from two marketed products, Gralise and Zipsor, significant royalty income from our partnered products and technology, a strong balance sheet and potential to turn cash flow positive in the second half of this year.”
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
SOURCE: Depomed
Post Views: 139
