Akorn, Ani and Novadoz Launch New Generic Products

Recent approvals include a first generic for the infertility drug Cetrotide, as well as generics of Revatio, Velcade and Esbriet.

Akorn has received approval for cetrorelix acetate for injection. This is the first approved AP‐Rated bioequivalent version of EMD Serono’s Cetrotide, which is used in women experiencing infertility. The FDA granted Akorn a competitive generic therapy designation for cetrorelix and has received 180 days of market exclusivity.

“We are pleased to announce the first approved AP‐rated generic option for women receiving fertility treatments,” Akorn president and CEO Douglas Boothe said in a press release.

Ani Pharmaceuticals’ dexamethasone tablets, which is a generic version of the steroid Decadron, which is used to treat allergic conditions, some endocrine and dermatologic conditions, as well as multiple sclerosis and rheumatic disorders.

Novadoz has received FDA approval and has seven new generic products, including three that have been manufactured in its new facility in New Jersey. Novadoz is owned by MSN Labs, based in Hyderabad, India.

The three oral solutions manufactured in the United States include sildenafil, a generic of Pfizer’s Revatio, used to treat patients with pulmonary arterial hypertension; valganciclovir a generic of Genentech’s Valcyte, used to treat patients with cytomegalovirus (CMV) retinitis in people who have acquired immunodeficiency syndrome (AIDS) and to prevent CMV in those who have received kidney, heart, kidney-pancreas transplant; and levetiracetam, a generic of UCB’s Keppra used to treat patients with seizures.

Other Novadoz generic products launched include:

• Pirfenidone tablets, a generic of Genentech’s Esbriet, used to treat idiopathic pulmonary fibrosis.

• Chlorpromazine tablets rated to Thorazine, a discontinued brand. It is used to treat schizophrenia, bipolar and mania

• Bortezomib for injection, a generic of Takeda’s Velcade, which is used to treat multiple myeloma and mantle cell lymphoma.

• Bumetanide, a generic Bumex, a diuretic developed by Validus Pharmaceuticals.