Mylan announced the launch of its Lidocaine Patch 5% in the United States, which is the generic version of Endo Pharmaceutical's Lidoderm.
Mylan states it received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for relief of pain associated with post-herpetic neuralgia.
Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (base) and 10 mg (base), and Rizatriptan Benzoate Tablets, 5 mg (base) and 10 mg (base). These products are the generic versions of Merck's Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.
Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
The U.S. Food and Drug Administration approved the abbreviated new drug application July 26. This new AB-rated product is the first approved generic for the Reference Listed Drug (RLD) Oxycodone HCl 5 mg capsules manufactured by Lehigh Valley Technologies Inc.
Eli Lilly and Co. today announced data from a Phase III trial comparing the effects of FORTEO (teriparatide [rDNA origin] injection) and risedronate on back pain in postmenopausal women with osteoporotic vertebral fractures.
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S.
Pain Therapeutics Inc. a biopharmaceutical company, today announced the issuance of four patents by the U.S. Patent and Trademark Office covering REMOXY (oxycodone) Extended-Release Capsules CII. These patents are the result of joint inventive work by scientists from both Pain Therapeutics and Durect Corporation. The four issued patents are licensed exclusively to Pain Therapeutics in the United States and international markets with regards to four opioid drugs.