(By Balaseshan) Mylan Inc. (NASDAQ: MYL) said its subsidiary launched the generic version of Merck & Co. Inc.'s (NYSE: MRK) Maxalt MLT and Maxalt tablets to treat acute migraine with or without aura in adults.
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).
Mylan is shipping the orally disintegrating and immediate-release versions of this product immediately.
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.
Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (base) and 10 mg (base), and was awarded 180 days of marketing exclusivity.
Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (base) and 10 mg (base), had U.S. sales of about $262.5 million for the twelve months ending September 30, 2012, according to IMS Health, and Rizatriptan Benzoate Tablets, 5 mg (base) and 10 mg (base), had U.S. sales of about $344.7 million for the same period.
On December 28, 2012, the company's partner Famy Care Ltd. has launched Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva (NYSE: TEVA) Branded Pharmaceutical Products' Nordette 28 Tablets.
The product will be distributed in the U.S. by Mylan Pharmaceuticals Inc., and the company is shipping product immediately. Nordette 28 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Mylan Pharmaceuticals also launched Phenytoin Chewable Tablets USP, 50 mg, which is the generic version of Pfizer's (NYSE: PFE) Dilantin Chewable Tablets. Mylan is shipping this product immediately.
Dilantin Tablets are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments
MYL is trading up 0.07% at $27.47 on Wednesday. The stock has been trading between $20.21 and $28.50 for the past 52 weeks.