According to the agency, Teva communicated that it would have difficulties supplying immediate release formulations of the drug due to manufacturing delays.
US FDA follows up the first generic approval of naloxone nasal spray by encouraging companies to apply with generic applications amid the North American opioid crisis.
The FDA approved Teva's generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition.
The decision, influenced by the expected loss of exclusivity for Restasis, will allow the company to ‘improve efficiencies’ across its manufacturing network, a spokesperson explained.
The US FDA has granted expiration date extensions for specific lots of Mylan’s EpiPen auto-injectors, as manufacturer Pfizer works to stabilise supply.
Teva Pharmaceutical Industries will reduce its workforce by 14,000, rejig its generics portfolio and speed up optimization of its plant network as part of a $3bn (€2.5bn) cost saving plan.
Teva has aggressively defended its market share for its blockbuster Copaxone says Momenta, six months after marketing partner Sandoz launched the first generic version in the US.
"People are the essence of the company going forward," said Teva, referring to the news that the world's largest generic drug maker will purchase Allergan's generics business for $40.5bn, at its Q2 financial results press conference...
Complex generics will represent over 50% of Teva’s generic market by 2017, the firm says, but investments in delivery technology will have positive implications across the full business.
Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.
Teva Pharmaceuticals is set to build its first Indian production plant after finalising a pact with healthcare giant Procter & Gamble (P&G), according to local authorities.
Quality issues slowed first quarter revenue growth at Teva but, with one plant resuming shipping and another awaiting re-inspection, sales are expected to pick up.
Teva plans to acquire oncology drugs that fail late-stage clinical trials and collaborate with Optimata to "efficiently rescue" the therapeutics and gain regulatory approval.
The US subsidiary of world leading generics firm Teva Pharmaceutical Industries has called in procurement specialist ICG Commerce to help it cut its outsourcing spend as part of ongoing cost reduction operations.
Pliva is laying off 790 employees over the next 12 months following its acquisition by Teva but still intends to significantly increase API and finished product output over this period.
Teva has made a big push into the biosimilars market through a joint venture with Lonza, which will give the generics giant expertise in biologics manufacture.
Watson Pharmaceuticals has paid Israeli generics firm Teva $36m (€27.6m) for 17 products that the latter firm is selling under the terms of its $7.5bn acquisition of Barr Pharmaceuticals.
Teva and Kowa have set their sights on Japan’s $4.6bn (€3.1bn) generics market with their development and manufacturing joint venture Teva-Kowa Pharma.
Teva's sales of active pharmaceutical ingredients (APIs) for the
first quarter of 2008 rose by 51 per cent on the previous years
figure, taking to total to $510m.
With active pharmaceutical ingredient sales of $1,460m (€960.8m) in
2007 and a portfolio of more than 250 compounds, Teva
Pharmaceutical Industries is by a long stretch the dominant
supplier in the global API market.
Looking for $45m (€35m) in savings, Teva has decided to abandon its
drug manufacturing plant in Cidra, Puerto Rico, as it scrambles to
adjust capacity seven months after its acquisition of Ivax.
CureTech has revealed it has wrapped up a deal in which Teva
Pharmaceuticals will invest $6m (€4.7m) in CureTech, for the
development of a revolutionary cancer drug, based on the company's
potential value of $64m.
Teva Pharmaceutical Industries continued its bid for world
domination in the generic pharmaceuticals sector yesterday with a
$7.4 billion cash and stock bid for US company Ivax, reports
Phil Taylor.