Hi-Tech and Mylan update on generics

US generic drugmaker Hi-Tech Pharmacal (Nasdaq: HITK) says that the US Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application for levetiracetam oral solution 100mg/mL, the generic for Belgian company UCB Pharma’s Keppra oral solution which had combined brand and generic sales of $62 million for the 12 months ended December 2011 according to IMS sales data.

The product is used to treat partial onset seizures in people 16 years of age and older with epilepsy. Hi-Tech plans to launch the product by May 2012. Hi-Tech currently has 14 products awaiting approval at the FDA, targeting brand and generic sales of over $1.5 billion. In addition, Hi-Tech has 20 products in active development targeting brand sales of over $3 billion, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.

Mylan debuts first generic Lexapro in USA

Mylan (Nasdaq: MYL) says that its subsidiary Mylan Pharmaceuticals has launched escitalopram tablets USP, 5mg, 10mg and 20mg, the first equivalent product to Forest Laboratories' Lexapro, which is used for acute and maintenance treatment of major depressive disorder (MDD) and acute treatment of generalized anxiety disorder (GAD).

Mylan will market this product exclusively until the expiration of the pediatric exclusivity on the compound patent, as per the settlement agreement between Mylan's Alphapharm subsidiary and Forest Laboratories.

Mylan chief executive Heather Bresch said: "We are extremely pleased to be the first company to offer the first equivalent product to Lexapro, allowing customers, payers and patients to realize significant savings from our high quality, more affordable treatment option."

Lexapro had US sales of approximately $2.9 billion for the 12 months ending December 31, 2011, according to IMS Health.